II 

114TH CONGRESS 

1ST SESSION S. 1014 

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 

of cosmetics. 

IN THE SENATE OF THE UNITED STATES 

APRIL 20, 2015 

Mrs. FEINSTEIN (for herself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

ensure the safety of cosmetics. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Personal Care Products Safety Act’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—COSMETIC SAFETY 

Sec. 101. Registration of cosmetics facilities and cosmetic ingredient statements. 


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Sec. 102. Review of ingredients and non-functional constituents; safety of finished products. 

Sec. 103. Good manufacturing practices for cosmetics. 

Sec. 104. Adverse event reports. 

Sec. 105. Records inspection; mandatory recall authority. 

Sec. 106. Labeling. 

Sec. 107. Coal tar chemicals. 

Sec. 108. Animal testing alternatives. 

Sec. 109. Preemption. 

Sec. 110. Reporting. 

Sec. 111. Small businesses. 

Sec. 112. Applicability with respect to certain cosmetics. 

Sec. 113. Enforcement. 

Sec. 114. Consumer information. 

TITLE II—FEES RELATED TO COSMETIC SAFETY 

Sec. 201. Findings. 

Sec. 202. Authority to assess and use cosmetic safety fees. 

Sec. 203. Direct hiring authority to support activities related to cosmetics. 

1 TITLE I—COSMETIC SAFETY 

2 SEC. 101. REGISTRATION OF COSMETICS FACILITIES AND 

3 COSMETIC INGREDIENT STATEMENTS. 

4 (a) AMENDMENTS.—Chapter VI of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amend6 ed by adding at the end the following: 

7 ‘‘SEC. 604. DEFINITIONS. 

8 ‘‘In this chapter: 

9 ‘‘(1) COSMETIC FORMULATION.—The term ‘cos10 metic formulation’ means a preparation of cosmetic 

11 raw materials with a qualitatively and quantitatively 

12 set composition. 

13 ‘‘(2) COSMETIC PRODUCT.—The term ‘cosmetic 

14 product’ means a cosmetic comprised of a specified 

15 set of ingredients, which may come in a range of 


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1 possible amounts for each ingredient and which may 

2 include a variety of fragrances, flavors, and colors. 

3 ‘‘(3) FACILITY.—The term ‘facility’ includes 

4 any factory, warehouse, or establishment (including 

5 a factory, warehouse, or establishment of an im6 porter) that manufactures, processes, packs, or holds 

7 cosmetic products or cosmetic formulations, or any 

8 other entity whose name and address appear on the 

9 label of a cosmetic product. Such term does not in10 clude— 

11 ‘‘(A) beauty shops and salons that do not 

12 otherwise manufacture, process, or package cos13 metics at that location; 

14 ‘‘(B) cosmetic product retailers, including 

15 individual sales representatives, retail distribu16 tion facilities, and pharmacies, that do not oth17 erwise manufacture, process, or package cos18 metics at that location; 

19 ‘‘(C) hospitals, physicians’ offices, and 

20 health care clinics; 

21 ‘‘(D) public health agencies and other non22 profit entities that provide cosmetics directly to 

23 the consumer; 

24 ‘‘(E) hotels and other entities that provide 

25 complimentary cosmetics to guests; 


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1 ‘‘(F) trade shows and other venues where 

2 cosmetic product samples are provided free of 

3 charge; 

4 ‘‘(G) domestic manufacturers with less 

5 than $100,000 in gross annual sales of cosmetic 

6 products; or 

7 ‘‘(H) entities that manufacture or com8 pound cosmetic products solely for use in re9 search, teaching, or pilot plant production and 

10 not for sale. 

11 ‘‘(4) FOREIGN FACILITY.—The term ‘foreign fa12 cility’ means a facility that manufactures, processes, 

13 packs, or holds, a cosmetic formulation or cosmetic 

14 product that is exported to the United States with15 out further processing or packaging inside the 

16 United States. A cosmetic is not considered to have 

17 undergone further processing or packaging for pur18 poses of this definition solely on the basis that label19 ing was added or that any similar activity of a de 

20 minimis nature was carried out with respect to the 

21 cosmetic. 

22 ‘‘(5) NON-FUNCTIONAL CONSTITUENT.—The 

23 term ‘non-functional constituent’ means any sub24 stance that is an incidental component of an ingre25 dient, a breakdown product of an ingredient or a byVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 product of the manufacturing process that has not 

2 been intentionally added as a separate substance and 

3 serves no technical function in the cosmetic. 

4 ‘‘(6) RESPONSIBLE PERSON.—The term ‘re5 sponsible person’ means— 

6 ‘‘(A) the brand owner who is the domestic 

7 or foreign manufacturer, packer, or entity 

8 whose name appears on a cosmetic product 

9 label of a cosmetic product distributed in the 

10 United States, except for entities described in 

11 subparagraphs (A) through (H) of paragraph 

12 (3); or 

13 ‘‘(B) a contract manufacturer who provides 

14 cosmetic products to the entities described in 

15 subparagraphs (A) through (H) of paragraph 

16 (3).’’. 

17 ‘‘SEC. 605. REGISTRATION OF COSMETIC FACILITIES. 

18 ‘‘(a) REGISTRATION AND FEES FOR EXISTING MAN19 UFACTURING OR PROCESSING OF COSMETICS.— 

20 ‘‘(1) REGISTRATION, IN GENERAL.—Not later 

21 than December 1, 2015, and at a similar time in 

22 each subsequent year, as determined by the Food 

23 and Drug Administration, each responsible person 

24 engaged in manufacturing or processing a cosmetic 

25 product or a cosmetic formulation distributed in the 


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1 United States shall register all of the responsible 

2 person’s facilities with the Food and Drug Adminis3 tration. 

4 ‘‘(2) FEES.—If the average gross annual sales 

5 in the United States of cosmetic products of all of 

6 the responsible person’s facilities registered under 

7 paragraph (1) for the previous 3-year period is 

8 greater than $500,000, a registration shall not be 

9 complete under this subsection until the responsible 

10 person has paid any registration fee required under 

11 section 744L. 

12 ‘‘(b) REGISTRATION FOR EXISTING PACKING OR

13 HOLDING OF COSMETICS.—Not later than December 1, 

14 2015, and at a similar time once every 3 years thereafter, 

15 as determined by the Food and Drug Administration, each 

16 person who owns or operates a cosmetic facility or facili17 ties engaged in packing or holding a cosmetic product dis18 tributed in the United States shall register each such facil19 ity with the Food and Drug Administration. 

20 ‘‘(c) REGISTRATION BY NEW FACILITIES.—Any facil21 ity first engaging after the date of enactment of the Per22 sonal Care Products Safety Act in an activity that would 

23 require it to register under subsection (a) or (b) shall reg24 ister with the Food and Drug Administration within 60 


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1 days of first engaging in such activity, and thereafter in 

2 accordance with subsection (a) or (b). 

3 ‘‘(d) CHANGES TO INFORMATION.—A registrant who 

4 has submitted a registration under this section shall notify 

5 the Food and Drug Administration of any change to the 

6 information required under subsection (a) or (b) not later 

7 than 60 days after the date of such change, unless other8 wise specified by the Food and Drug Administration. 

9 ‘‘(e) FORMAT; CONTENTS.— 

10 ‘‘(1) ELECTRONIC FORMAT.—Each registration 

11 shall be submitted using an electronic format, as 

12 specified in a registration form provided by the Food 

13 and Drug Administration. 

14 ‘‘(2) CONTENTS.—The registration shall con15 tain the following information: 

16 ‘‘(A) Each facility’s name and full address, 

17 identifying the precise physical location of the 

18 facility. 

19 ‘‘(B) The identity of the facility, including 

20 the unique facility identifier, if any, previously 

21 assigned by the Food and Drug Administration 

22 to the facility under subsection (g). 

23 ‘‘(C) All business trading names used by 

24 the facility. 


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1 ‘‘(D) The product category or categories of 

2 each cosmetic product or cosmetic formulation 

3 manufactured, processed, packed, or held at the 

4 facility or on whose label the facility’s name 

5 and address appear. 

6 ‘‘(E) The type of activity conducted at the 

7 facility (such as manufacturing, processing, 

8 packing, or holding). 

9 ‘‘(F) The name, title, street address, tele10 phone number, and electronic contact informa11 tion of the emergency contact for the facility. 

12 ‘‘(G) In the case of a foreign facility, the 

13 name, street address, telephone number, emer14 gency contact information for the facility, the 

15 name of the United States agent for the facil16 ity, and, if available, the electronic contact in17 formation of the United States agent. 

18 ‘‘(H) The name, title, street address, tele19 phone number, and electronic contact informa20 tion of the individual submitting the registra21 tion. 

22 ‘‘(I) An assurance that the Food and Drug 

23 Administration will be permitted to inspect such 

24 facility at the times and in the manner per25 mitted by this Act. 


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1 ‘‘(J) Additional information pertaining to 

2 the facility or to the cosmetic products or cos3 metic formulations manufactured, processed, 

4 packed, or held at the facility, or on whose label 

5 the facility’s name and address appear, includ6 ing all brand names known to consumers, as 

7 the Food and Drug Administration may require 

8 by regulation. 

9 ‘‘(3) ABBREVIATED REGISTRATION.—The Food 

10 and Drug Administration shall provide for an abbre11 viated registration renewal process for any registrant 

12 that has not had any changes to such information 

13 with respect to the facility or facilities involved since 

14 the registrant submitted the preceding registration. 

15 ‘‘(f) INCOMPLETE OR INACCURATE REGISTRATION.— 

16 ‘‘(1) IN GENERAL.—Not earlier than 10 days 

17 after providing notice of the intent to cancel a reg18 istration and the basis for such cancellation, the 

19 Food and Drug Administration may cancel a reg20 istration under this section if the Food and Drug 

21 Administration has reasonable grounds to believe 

22 that the registration was not properly completed or 

23 updated in accordance with this section or otherwise 

24 contains false, incomplete, or inaccurate information. 


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1 ‘‘(2) TIMELY UPDATE OR CORRECTION.—If, not 

2 later than 7 days after receipt of a notice of intent 

3 to cancel, the sponsor corrects the registration in ac4 cordance with the basis for the cancellation, and the 

5 required registration fee, if any, is paid, the Food 

6 and Drug Administration shall not cancel such reg7 istration. 

8 ‘‘(g) UNIQUE IDENTIFIER.—At the time of the initial 

9 registration of any cosmetic facility under this section, the 

10 Food and Drug Administration shall assign a unique iden11 tifier to the facility. 

12 ‘‘(h) REGISTRY OF FACILITIES.— 

13 ‘‘(1) IN GENERAL.—The Food and Drug Ad14 ministration shall compile, maintain, and update a 

15 registry of facilities that are registered under this 

16 section, and shall remove from such registry the 

17 name of any facility whose registration under this 

18 section is cancelled. The registry shall be publicly 

19 available. 

20 ‘‘(2) PUBLIC AVAILABILITY EXCEPTIONS.—In21 formation derived from the registry or registration 

22 documents that discloses the residential address of a 

23 registrant or that discloses specific facilities where 

24 specific cosmetic products are manufactured or procVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 essed shall not be subject to disclosure under section 

2 552 of title 5, United States Code. 

3 ‘‘SEC. 606. COSMETIC INGREDIENT STATEMENTS. 

4 ‘‘(a) IN GENERAL.—For each cosmetic product, the 

5 responsible person shall submit to the Food and Drug Ad6 ministration a cosmetic ingredient statement, at such time 

7 and in such manner as the Food and Drug Administration 

8 may prescribe. The cosmetic ingredient statement shall 

9 not become effective until the responsible person pays any 

10 applicable fee required under section 744L. 

11 ‘‘(b) SUBMISSION OF A COSMETIC INGREDIENT

12 STATEMENT.— 

13 ‘‘(1) EXISTING COSMETIC PRODUCTS.—In the 

14 case of a cosmetic product that is marketed on the 

15 date of enactment of the Personal Care Products 

16 Safety Act, the responsible person shall submit a 

17 cosmetic ingredient statement not later than Decem18 ber 1, 2015. The responsible person shall submit to 

19 the Food and Drug Administration a renewal of 

20 such statement on a yearly basis. 

21 ‘‘(2) COSMETIC INGREDIENT STATEMENT FOR

22 NEW COSMETIC PRODUCTS.— 

23 ‘‘(A) IN GENERAL.—Except as provided 

24 under subparagraph (B), in the case of a cos25 metic product that is first marketed after the 


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1 date of enactment of the Personal Care Prod2 ucts Safety Act or a cosmetic product that is 

3 reformulated after such date of enactment, the 

4 responsible person shall submit a cosmetic in5 gredient statement to the Food and Drug Ad6 ministration within 60 days of first marketing 

7 the new cosmetic product or the reformulated 

8 cosmetic product, and annually thereafter. 

9 ‘‘(B) SMALL BUSINESSES.—The Food and 

10 Drug Administration shall allow a responsible 

11 person that is a business that meets the appli12 cable industry-based small business size stand13 ard established by the Administrator of the 

14 Small Business Administration under section 3 

15 of the Small Business Act to have a period 

16 longer than 60 days to submit an initial new 

17 cosmetic ingredient statement under subpara18 graph (A). Such responsible person shall submit 

19 a cosmetic ingredient statement annually there20 after. 

21 ‘‘(C) DEFINITION.—A cosmetic product 

22 shall not be considered first marketed or refor23 mulated after the date of enactment under sub24 paragraph (A) if the only change in such prod25 uct is in— 


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1 ‘‘(i) the amount of an existing ingre2 dient if it is within the range previously re3 ported under subsection (c)(2)(E); or 

4 ‘‘(ii) the addition or subtraction of a 

5 fragrance, flavor, or color, or such other 

6 interchangeable ingredients specified by 

7 the Food and Drug Administration in reg8 ulations or guidance, previously reported 

9 as a potential ingredient under subsection 

10 (c)(2)(E), if, in the case of such an addi11 tion, the amount is within the range pre12 viously reported. 

13 ‘‘(c) FORMAT; CONTENTS.— 

14 ‘‘(1) FORM.—For each cosmetic product, the 

15 cosmetic ingredient statement shall be submitted 

16 using an electronic format, as specified in a cosmetic 

17 and ingredient form provided by the Food and Drug 

18 Administration. 

19 ‘‘(2) CONTENTS.—The cosmetic ingredient 

20 statement shall include the following information: 

21 ‘‘(A) The unique identifier, assigned under 

22 section 605(g), as applicable, of— 

23 ‘‘(i) the facility or facilities where the 

24 cosmetic product is manufactured, proc25 essed, packed, or held or, if the same cosVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 metic product is manufactured, processed, 

2 packed, or held in more than one facility, 

3 the unique facility identifier of each facility 

4 where it is manufactured, processed, 

5 packed, or held; and 

6 ‘‘(ii) the facility whose name and ad7 dress appear on the label, unless the state8 ment is filed by a contract manufacturer, 

9 described in section 604(6)(B). 

10 ‘‘(B) The brand name and the full name 

11 for the cosmetic product as it appears on the 

12 label. 

13 ‘‘(C) The cosmetic product listing number, 

14 if any, previously assigned by the Food and 

15 Drug Administration under subsection (f) to 

16 the cosmetic product. 

17 ‘‘(D) The applicable cosmetic category for 

18 the cosmetic product. 

19 ‘‘(E) A list of ingredients in the cosmetic 

20 product, including a range of possible amounts 

21 of each ingredient, and with each ingredient 

22 identified by the name adopted in regulations 

23 promulgated by the Food and Drug Adminis24 tration, if any, or by the common or usual 


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1 name of the ingredient. The cosmetic ingredient 

2 statement shall contain— 

3 ‘‘(i) a list of fragrances, flavors, and 

4 colors that may be included in the product, 

5 interchangeably, with ranges of possible 

6 amounts, which shall include— 

7 ‘‘(I) in the case of fragrances 

8 that are purchased from a fragrance 

9 supplier, the fragrances shall be iden10 tified by the name or code provided by 

11 the supplier, and include the name 

12 and contact information for the fra13 grance supplier; 

14 ‘‘(II) in the case of flavors that 

15 are purchased from a flavor supplier, 

16 the flavors shall be identified by the 

17 name or code provided by the sup18 plier, and include the name and con19 tact information for the flavor sup20 plier; and 

21 ‘‘(III) in the case of a notifica22 tion provided by the Food and Drug 

23 Administration to the responsible per24 son for the cosmetic manufacturer, 

25 the Food and Drug Administration 


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1 may request, from the fragrance or 

2 flavor supplier, the complete list of in3 gredients in specific fragrances or fla4 vors and the supplier shall have 30 

5 days to provide such list to the Food 

6 and Drug Administration; and 

7 ‘‘(ii) other appropriate interchange8 able ingredients as the Food and Drug Ad9 ministration may specify in regulations or 

10 guidance that may be included in the prod11 uct, with ranges of possible amounts. 

12 ‘‘(F) The title and full contact information 

13 of each individual submitting the statement. 

14 ‘‘(G) If applicable, information on the la15 beling required under section 614. 

16 ‘‘(H) Such additional information per17 taining to the cosmetic product as the Food and 

18 Drug Administration may require. 

19 ‘‘(3) COSMETIC INGREDIENT STATEMENT FOR

20 CERTAIN SMALL BUSINESSES.— 

21 ‘‘(A) IN GENERAL.—Notwithstanding any 

22 other provision of this subsection, the Food and 

23 Drug Administration may permit a simplified 

24 cosmetic ingredient statement under this sec25 tion for a responsible person that— 


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1 ‘‘(i) is a business that meets the appli2 cable industry-based small business size 

3 standard established by the Administrator 

4 of the Small Business Administration 

5 under section 3 of the Small Business Act; 

6 and 

7 ‘‘(ii) has had an average of less than 

8 $500,000 in annual domestic cosmetic 

9 sales over the previous 3 years. 

10 ‘‘(B) CONTENTS.—A responsible person 

11 described in subparagraph (A) shall include in 

12 each cosmetic ingredient statement under this 

13 section, at a minimum, a list of ingredients in 

14 the cosmetic product and the applicable cos15 metic category for the cosmetic product. 

16 ‘‘(d) INCOMPLETE OR INACCURATE COSMETIC IN17 GREDIENT STATEMENT.— 

18 ‘‘(1) IN GENERAL.—Not earlier than 10 days 

19 after providing notice under paragraph (2), the Food 

20 and Drug Administration may nullify a cosmetic in21 gredient statement filed under this section if the 

22 Food and Drug Administration has reasonable 

23 grounds to believe that the cosmetic ingredient state24 ment was not completed or updated in accordance 


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1 with this section or otherwise contains false, incom2 plete, or inaccurate information. 

3 ‘‘(2) NOTICE OF NULLIFICATION.—A nullifica4 tion under paragraph (1) shall be preceded by notice 

5 to the responsible person of the intent to cancel the 

6 cosmetic ingredient statement and the basis for such 

7 cancellation. 

8 ‘‘(3) TIMELY UPDATE OR CORRECTION.—If the 

9 cosmetic ingredient statement is appropriately up10 dated or corrected not later than 7 days after notice 

11 is provided under paragraph (1), the Food and Drug 

12 Administration shall not nullify such cosmetic ingre13 dient statement. 

14 ‘‘(e) ADDITIONAL REQUIREMENTS.— 

15 ‘‘(1) SAFETY REQUIREMENTS.—In filing each 

16 cosmetic ingredient statement cosmetic product, the 

17 responsible person shall include an attestation that 

18 the safety of the product, including the individual in19 gredients of such product and the product as a 

20 whole, has been substantiated in accordance with 

21 section 609. In the case of a cosmetic ingredient 

22 statement that includes a range of possible amounts 

23 (as described in subsection (c)(2)(E)), the respon24 sible person shall include an attestation that the 


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1 safety of the full range in the finished product has 

2 been substantiated, in accordance with section 609. 

3 ‘‘(2) ABBREVIATED FILING.—The Food and 

4 Drug Administration shall provide for an abbre5 viated renewal process for any such filing with re6 spect to which there has been no change since the 

7 responsible person submitted the previous filing. 

8 ‘‘(3) CHANGES TO INFORMATION.— 

9 ‘‘(A) IN GENERAL.—Except as provided in 

10 subparagraph (B), the responsible person shall 

11 notify the Food and Drug Administration with12 in 60 days of any change to the information re13 quired to be in a cosmetic ingredient statement, 

14 including discontinuation of the manufacture of 

15 a cosmetic product, except that notification 

16 under this paragraph is not required for a 

17 change in— 

18 ‘‘(i) the amount of an existing ingre19 dient if it is within the range previously re20 ported under subsection (c)(2)(E); or 

21 ‘‘(ii) the addition or subtraction of a 

22 fragrance, flavor, or color, or such other 

23 interchangeable ingredients specified by 

24 the Food and Drug Administration in reg25 ulations or guidance, previously reported 


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1 as a potential ingredient under subsection 

2 (c)(2)(E), if, in the case of an addition of 

3 such an ingredient, the amount is within 

4 the range previously reported. 

5 ‘‘(B) SMALL BUSINESS.—The Food and 

6 Drug Administration shall allow a responsible 

7 person that is a business that meets the appli8 cable industry-based small business size stand9 ard established by the Administrator of the 

10 Small Business Administration under section 3 

11 of the Small Business Act to have a period 

12 longer than 60 days, but not longer than the 

13 next annual registration deadline under section 

14 605(a)(1), to submit any change to the infor15 mation required to be in a cosmetic ingredient 

16 statement as described in subparagraph (A). 

17 ‘‘(f) COSMETIC PRODUCTS LIST.—At the time of the 

18 initial submission of any cosmetic ingredient statement 

19 under this section, the Food and Drug Administration 

20 shall assign a unique cosmetic product listing number to 

21 the cosmetic ingredient statement. Based on such cosmetic 

22 ingredient statements, the Food and Drug Administration 

23 shall compile and maintain a list of cosmetic products dis24 tributed in the United States, including the ingredients 

25 of each such product, and shall make available such list 


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1 to any State, upon request. Information disclosed to a 

2 State that is exempt from disclosure under section 

3 552(b)(4) of title 5, United States Code, shall be treated 

4 as a trade secret and confidential information by the 

5 State. 

6 ‘‘SEC. 607. SUSPENSION OF REGISTRATION OR COSMETIC 

7 INGREDIENT STATEMENT. 

8 ‘‘(a) SUSPENSION OF REGISTRATION OF A FACIL9 ITY.—If the Food and Drug Administration determines 

10 that a cosmetic formulation or cosmetic product manufac11 tured, processed, packed, or held by a registered facility 

12 has a reasonable probability of causing serious adverse 

13 health consequences or death to humans, and there is rea14 son to believe that other formulations or products manu15 factured, processed, packed, or held by the facility may 

16 be similarly affected because of a failure affecting multiple 

17 products in that facility, the Food and Drug Administra18 tion may suspend the registration of a facility. 

19 ‘‘(b) SUSPENSION OF COSMETIC INGREDIENT STATE20 MENT.—If the Food and Drug Administration determines 

21 that a cosmetic product manufactured in a registered fa22 cility has a reasonable probability of causing serious ad23 verse health consequences or death to humans, the Food 

24 and Drug Administration may suspend the cosmetic ingre25 dient statement of that product. 


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1 ‘‘(c) NOTICE OF SUSPENSION.—Before suspending a 

2 facility registration or a cosmetic ingredient statement 

3 under this section, the Food and Drug Administration 

4 shall provide— 

5 ‘‘(1) notice to the facility registrant of the cos6 metic product or formulation or other responsible 

7 person, as appropriate, of the intent to suspend the 

8 facility registration or the cosmetic ingredient state9 ment, which shall specify the basis of the determina10 tion by the Food and Drug Administration that the 

11 facility or the cosmetic ingredient should be sus12 pended and recommendations for specific actions to 

13 avoid suspension; and 

14 ‘‘(2) an opportunity, within 2 business days of 

15 the notice provided under paragraph (1), for the re16 sponsible person to address the reasons for possible 

17 suspension of the facility registration or cosmetic in18 gredient statement. 

19 ‘‘(d) REINSTATEMENT.—Upon a determination by 

20 the Food and Drug Administration that adequate grounds 

21 do not exist to continue the suspension actions, the Food 

22 and Drug Administration shall promptly vacate the sus23 pension and reinstate the registration of the facility or the 

24 cosmetic ingredient statement. 

25 ‘‘(e) EFFECT OF SUSPENSION.— 


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1 ‘‘(1) REGISTRATION.—If the registration of a 

2 facility is suspended under this section, no person 

3 shall import or export cosmetics or otherwise dis4 tribute cosmetics from such facility. 

5 ‘‘(2) COSMETIC INGREDIENT STATEMENT.—If 

6 the cosmetic ingredient statement for a cosmetic 

7 product is suspended under this section, no person 

8 shall import or export such cosmetic product or oth9 erwise distribute in the United States such cosmetic 

10 product that is the subject of such statement. 

11 ‘‘(f) NO DELEGATION.—The authority conferred by 

12 this section to issue an order to suspend a registration 

13 or vacate an order of suspension shall not be delegated 

14 to any officer or employee other than the Commissioner.’’. 

15 SEC. 102. REVIEW OF INGREDIENTS AND NON-FUNCTIONAL 

16 CONSTITUENTS; SAFETY OF FINISHED PROD17 UCTS. 

18 (a) AMENDMENTS.—Chapter VI of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

20 amended by section 101, is further amended by adding 

21 at the end the following: 

22 ‘‘SEC. 608. REVIEW OF INGREDIENTS AND NON-FUNC23 TIONAL CONSTITUENTS. 

24 ‘‘(a) INGREDIENTS AND NON-FUNCTIONAL CON25 STITUENTS SUBJECT TO REVIEW.— 


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1 ‘‘(1) IN GENERAL.—Beginning in fiscal year 

2 2016, the Food and Drug Administration shall re3 view the safety of the cosmetic ingredients and non4 functional constituents under paragraph (3), as 

5 modified under subsection (c), if applicable, and 

6 issue an order under subsection (d) with respect to 

7 the use of each such ingredient and presence of each 

8 such non-functional constituent. 

9 ‘‘(2) PUBLIC NOTICE AND COMMENT.—At the 

10 initiation of the review of each cosmetic ingredient 

11 or non-functional constituent, the Food and Drug 

12 Administration shall open a docket for the submis13 sion of public comment and additional data relevant 

14 to the safety of the ingredient or non-functional con15 stituent. The Food and Drug Administration shall 

16 provide 60 days for public comment. 

17 ‘‘(3) COSMETIC INGREDIENTS.— 

18 ‘‘(A) INGREDIENTS TO BE CONSIDERED IN

19 FIRST YEAR.—During fiscal year 2016, the 

20 Food and Drug Administration shall initiate the 

21 review for safety of the following cosmetic in22 gredients: 

23 ‘‘(i) Diazolidinyl urea. 

24 ‘‘(ii) Lead acetate. 


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1 ‘‘(iii) Methylene glycol/methanediol/ 

2 formaldehyde. 

3 ‘‘(iv) Propyl paraben. 

4 ‘‘(v) Quaternium-15. 

5 ‘‘(B) INGREDIENTS TO BE CONSIDERED IN

6 SUBSEQUENT YEARS.— 

7 ‘‘(i) IN GENERAL.—Beginning in fis8 cal year 2017, the Food and Drug Admin9 istration shall annually select and complete 

10 a review of at least 5 cosmetic ingredients 

11 or non-functional constituents that were 

12 not reviewed in the prior 3 years from a 

13 list determined in consultation with indus14 try and consumer groups for review of 

15 safety. The Food and Drug Administration 

16 may modify such list under subsection (c). 

17 ‘‘(ii) CONSIDERATIONS.—The deter18 mination of which ingredients or functional 

19 ingredients will be reviewed in a given year 

20 shall be publicized in annual reports to 

21 Congress and the public, in accordance 

22 with section 618, and subject to consulta23 tion as provided for in clause (iii). The re24 view of any cosmetic ingredient or non25 functional constituent shall commence with 


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1 a public announcement by the Food and 

2 Drug Administration and the opening of a 

3 docket as required under paragraph (2). 

4 ‘‘(iii) CONSULTATION.—The Food and 

5 Drug Administration shall establish a Cos6 metics Safety Advisory Committee, which 

7 shall include equal numbers of individuals 

8 from the cosmetics industry and consumer 

9 groups, and other individuals, as the Food 

10 and Drug Administration determines ap11 propriate, including medical practitioners. 

12 Such advisory committee shall advise the 

13 Food and Drug Administration on cos14 metic ingredients and non-functional con15 stituents to be considered for review, sum16 marize public comments received pursuant 

17 to paragraph (4), and recommend 5 cos18 metic ingredients or non-functional con19 stituents to be reviewed for safety each 

20 year, as described in clause (i). The Food 

21 and Drug Administration may consult with 

22 the Cosmetics Safety Advisory Committee 

23 on other matters pertaining to cosmetic 

24 safety. 


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1 ‘‘(4) COMMENT PERIOD.—As part of the annual 

2 reporting to Congress and the public under section 

3 618, the Food and Drug Administration shall solicit 

4 public comment on which cosmetic ingredients or 

5 non-functional constituents on the list are of great6 est interest to be reviewed next for early review and 

7 which additional cosmetic ingredients or non-func8 tional constituents should be added to the list. The 

9 public may submit comments to the Food and Drug 

10 Administration at any time during the year regard11 ing which cosmetic ingredients or non-functional 

12 constituents of interest that the Food and Drug Ad13 ministration may consider during that year or subse14 quent years. 

15 ‘‘(b) LIST.—The Food and Drug Administration 

16 shall maintain a list, posted on the Internet website of the 

17 Food and Drug Administration, of the cosmetic ingredi18 ents and non-functional constituents for which final orders 

19 have been issued under subsection (d)(3), the finding 

20 made for each such ingredient or non-functional con21 stituent under subsection (d)(4), as modified by any order 

22 under subsection (f), and, if applicable, compliance dates 

23 that are the subject of a final order under subsection (e). 

24 ‘‘(c) INITIATIVE OF THE FDA.—The Food and Drug 

25 Administration may at any time, after consultation with 


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1 the Cosmetics Safety Advisory Committee, propose the 

2 issuance of an order on the safety of a cosmetic ingredient 

3 or non-functional constituent that was not previously list4 ed in subsection (a) or under section 618(a)(3). 

5 ‘‘(d) DETERMINATION ON SAFETY.— 

6 ‘‘(1) INITIAL PROPOSED ADMINISTRATIVE

7 ORDER.—Following consideration of data and com8 ments to the public docket and any other informa9 tion before the Food and Drug Administration, the 

10 Food and Drug Administration shall determine 

11 whether there is adequate evidence to make an ini12 tial finding on the safety of the ingredient or non13 functional constituent. If the Food and Drug Ad14 ministration determines that there is adequate evi15 dence, the Food and Drug Administration shall issue 

16 a proposed administrative order and shall post such 

17 order on the Internet website of the Food and Drug 

18 Administration, notwithstanding subchapter II of 

19 chapter 5 of title 5, United States Code. 

20 ‘‘(2) PUBLIC COMMENT.—Upon publication of 

21 the proposed administrative order described in para22 graph (1), the Food and Drug Administration shall 

23 open a docket for the submission of public comment. 

24 The Food and Drug Administration shall provide 30 


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1 days for public comment following publication of the 

2 proposed administrative order. 

3 ‘‘(3) FINAL ADMINISTRATIVE ORDER.—Fol4 lowing the public comment period described in para5 graph (2) and consideration of comments to the pub6 lic docket and any other information before the Food 

7 and Drug Administration, the Food and Drug Ad8 ministration shall determine whether there is ade9 quate evidence to make a final finding on the safety 

10 of the ingredient or non-functional constituent. If 

11 the Food and Drug Administration determines that 

12 there is adequate evidence, the Food and Drug Ad13 ministration shall issue a final administrative order 

14 and shall post such order on the Internet website of 

15 the Food and Drug Administration, notwithstanding 

16 subchapter II of chapter 5 of title 5, United States 

17 Code. 

18 ‘‘(4) DETERMINATIONS.—In the proposed ad19 ministrative order or the final administrative order, 

20 as applicable, the Food and Drug Administration 

21 shall make a determination that the ingredient or 

22 non-functional constituent is— 

23 ‘‘(A) safe in cosmetic products under speci24 fied conditions of use or tolerances; 


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1 ‘‘(B) safe in cosmetic products without the 

2 need for specified conditions of use or toler3 ances; or 

4 ‘‘(C) not safe in cosmetic products. 

5 ‘‘(5) CONDITIONS OF USE AND TOLERANCES.— 

6 An order under paragraph (4)(A) shall include such 

7 conditions on the use of an ingredient or such toler8 ances on the presence of a non-functional con9 stituent as are necessary for the safety of cosmetic 

10 products containing such ingredient or non-func11 tional constituent, including— 

12 ‘‘(A) limits on the amount or concentration 

13 of the ingredient or non-functional constituent 

14 that may be present in a cosmetic product, in15 cluding limits in products intended for children 

16 and other vulnerable populations, and limits on 

17 use near the eye or mucosal membranes; 

18 ‘‘(B) warnings that are necessary or appro19 priate under section 614, including warnings re20 lated to use by children, pregnant women, popu21 lations with high exposure to the ingredient 

22 (such as workers who are exposed through pro23 duction practices or handling of final products), 

24 or other vulnerable populations, to help ensure 


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1 safe use of cosmetic products containing the in2 gredient or non-functional constituent; and 

3 ‘‘(C) such other conditions as are nec4 essary for the safety of cosmetic products con5 taining such ingredient or non-functional con6 stituent. 

7 ‘‘(6) PUBLIC NOTICE.—A final order under this 

8 subsection shall set forth the determination of the 

9 Food and Drug Administration on safety, any condi10 tions of use or tolerances under subparagraph (A) or 

11 (B) of paragraph (4) and a summary of the valid 

12 scientific evidence supporting the finding. The order 

13 shall be effective upon its publication on the Internet 

14 website of the Food and Drug Administration and 

15 shall be considered final agency action. 

16 ‘‘(e) ORDER.—If the Food and Drug Administration 

17 issues a final administrative order under subparagraph 

18 (A) or (C) of subsection (d)(4), the Food and Drug Ad19 ministration shall, at the same time as publication of the 

20 notice under subsection (d)(6), publish a proposed order 

21 identifying dates by which use of the ingredient or non22 functional constituent in cosmetic products shall comply 

23 with the final administrative order, and provide 60 days 

24 for public comment, including comment on whether com25 pliance is feasible within the proposed dates. After considVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 ering comments on the proposed order, the Food and 

2 Drug Administration shall publish in the Federal Register 

3 a final order. 

4 ‘‘(f) MODIFICATION OF AN ORDER.—An order issued 

5 under subsection (d) or (e) may be modified or revoked 

6 by the Food and Drug Administration on the initiative of 

7 the Food and Drug Administration or in response to a 

8 petition. 

9 ‘‘(g) INADEQUATE EVIDENCE.— 

10 ‘‘(1) NOTICE; EXTENSION.—If the Food and 

11 Drug Administration determines that the available 

12 data and information are not adequate to make a 

13 proposed or final determination regarding safety 

14 under subsection (d)(4), with respect to a cosmetic 

15 ingredient or non-functional constituent, the Food 

16 and Drug Administration shall— 

17 ‘‘(A) publish such finding on the Internet 

18 website of the Food and Drug Administration 

19 not later than 90 days after the close of the rel20 evant comment period for the ingredient or 

21 non-functional constituent under subsection 

22 (a)(2), in the case of a proposed order, or sub23 section (d)(2), in the case of a final order; and 

24 ‘‘(B)(i) include a notice providing inter25 ested persons an additional 30 days from the 


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1 notice date to provide additional data and infor2 mation; and 

3 ‘‘(ii) if, after the 30-day period under 

4 clause (i), the Food and Drug Administration 

5 determines that additional safety substantiation 

6 with respect to such ingredient or non-func7 tional constituent is necessary to make a safety 

8 determination, include a notice specifying an 

9 additional time period, not to exceed 18 months 

10 from the notice date, and plan to obtain such 

11 data and information. 

12 ‘‘(2) DETERMINATION; ORDER.— 

13 ‘‘(A) INADEQUATE DATA AND INFORMA14 TION.—If the Food and Drug Administration 

15 determines, after considering any additional 

16 data and information submitted under para17 graph (1)(B), that the available data and infor18 mation still are not adequate to make a deter19 mination regarding safety under subsection 

20 (d)(4), the Food and Drug Administration 

21 shall, within 90 days of the close of the addi22 tional time period provided under paragraph 

23 (1)(B), issue a proposed order or a final admin24 istrative order— 


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1 ‘‘(i) making a determination that the 

2 ingredient or non-functional constituent 

3 has not been shown to be safe in cosmetic 

4 products; and 

5 ‘‘(ii) explaining why the available data 

6 and information are not adequate to assess 

7 the safety of the ingredient or non-func8 tional constituent. 

9 ‘‘(B) ADEQUATE DATA AND INFORMA10 TION.—If the Food and Drug Administration 

11 determines, after considering any additional 

12 data and information submitted under para13 graph (1)(B), that the available data and infor14 mation are adequate to make a determination 

15 regarding safety under subsection (d)(4), the 

16 Food and Drug Administration shall, within 

17 180 days of the close of the comment period, 

18 issue a proposed order, followed by a final 

19 order, on such cosmetic ingredient or non-func20 tional constituent, in accordance with such sub21 section. 

22 ‘‘(h) SAFETY ASSESSMENT.— 

23 ‘‘(1) IN GENERAL.—In assessing the safety of 

24 an ingredient or non-functional constituent, the 

25 Food and Drug Administration shall consider whethVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 er there is adequate evidence to support a reasonable 

2 certainty among competent scientists that the ingre3 dient is not harmful under the recommended or sug4 gested conditions of use or customary or usual use, 

5 or that a non-functional constituent is not harmful 

6 under the recommended or suggested tolerance levels 

7 or the level at which it is customarily or usually 

8 present. The Food and Drug Administration may 

9 not consider an ingredient or non-functional con10 stituent harmful solely because it can cause minor 

11 adverse health reactions, such as minor transient al12 lergic reactions or minor transient skin irritations, 

13 in some users. 

14 ‘‘(2) FACTORS.—In assessing the safety of an 

15 ingredient or non-functional constituent, the Food 

16 and Drug Administration shall consider, among 

17 other relevant factors, the following: 

18 ‘‘(A) The probable human exposure to the 

19 ingredient or non-functional constituent from 

20 expected use in cosmetics. 

21 ‘‘(B) The probable cumulative and aggre22 gate effect in humans of relevant exposure to 

23 the ingredient or non-functional constituent or 

24 to any chemically or pharmacologically related 

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1 ucts with similar routes of exposure under rec2 ommended or suggested conditions of use or 

3 their customary use, to the extent adequate 

4 data is available for analysis. In appropriate 

5 cases, the Food and Drug Administration may 

6 consider available information on the total expo7 sure to an ingredient or non-functional con8 stituent from all sources. 

9 ‘‘(C) Whether warnings or recommenda10 tions in a product label, as part of any condi11 tions of use or tolerances imposed by the Food 

12 and Drug Administration, would be necessary 

13 and appropriate to help ensure the safety of the 

14 ingredient or non-functional constituent. 

15 ‘‘(3) DATA AND INFORMATION.— 

16 ‘‘(A) REQUIRED INFORMATION.—A deter17 mination that an ingredient or non-functional 

18 constituent is safe in cosmetics shall be based 

19 upon adequate evidence submitted or otherwise 

20 known to the Food and Drug Administration, 

21 which shall include full reports of all available 

22 studies, published or unpublished, that are ade23 quately designed to show whether the ingredient 

24 or non-functional constituent is safe. Such stud25 ies may include in vitro and in silico studies 


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1 and epidemiological studies, biomonitoring stud2 ies, and studies focused on various points dur3 ing the lifespan of the subject, that use scientif4 ically valid methodology. 

5 ‘‘(B) ADDITIONAL RELEVANT INFORMA6 TION.—The Food and Drug Administration 

7 shall consider any other relevant information 

8 related to the safety of the ingredient or non9 functional constituent, including— 

10 ‘‘(i) adverse event reports; 

11 ‘‘(ii) findings and information from 

12 State, Federal, national, and international 

13 entities and other bodies composed of sci14 entific and medical experts; 

15 ‘‘(iii) if the ingredient or non-func16 tional constituent is lawfully used or 

17 present in other products regulated by the 

18 Food and Drug Administration, the sci19 entific basis for such use; and 

20 ‘‘(iv) experience with the ingredient or 

21 non-functional constituent in products that 

22 are distributed in the United States or in 

23 other countries, if such experience is well24 documented and has resulted in substantial 


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1 human exposure to the ingredient or non2 functional constituent over time.’’. 

3 ‘‘SEC. 609. SAFETY OF FINISHED COSMETIC PRODUCTS. 

4 ‘‘(a) DETERMINATION.— 

5 ‘‘(1) IN GENERAL.—Each responsible person 

6 for a finished cosmetic product shall, before first dis7 tributing the product for sale, make a written deter8 mination that the product is safe under the condi9 tions of use recommended in the labeling of the 

10 product. Such determination shall be based on ade11 quate evidence that each ingredient in the finished 

12 product is safe for the use recommended or sug13 gested in the labeling of the product and that the 

14 finished product is safe. 

15 ‘‘(2) NEW INFORMATION.—If new information 

16 relevant to the determination becomes available, the 

17 responsible person shall promptly update the deter18 mination to address that information. 

19 ‘‘(3) SAFETY WITH RESPECT TO RANGES OF

20 POSSIBLE AMOUNTS.—In the case of a cosmetic 

21 product for which there is a range of possible 

22 amounts of cosmetic ingredients included in the cos23 metic ingredient statement, as described in section 

24 606(c)(2)(E), the safety determination under paraVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 graph (1) shall include substantiation of the safety 

2 of the full range in the finished product. 

3 ‘‘(b) PRESUMPTION OF ADEQUATE EVIDENCE.— 

4 ‘‘(1) IN GENERAL.—Except as provided in sub5 section (c), a determination made under subsection 

6 (a) shall be presumed to be based on adequate evi7 dence if it is supported by— 

8 ‘‘(A) with respect to each ingredient in the 

9 finished product— 

10 ‘‘(i) references to an official statement 

11 by one or more expert medical or scientific 

12 bodies that the ingredient is safe under the 

13 conditions of use recommended or sug14 gested in the product’s labeling; or 

15 ‘‘(ii) appropriate safety testing of the 

16 ingredient; and 

17 ‘‘(B) appropriate safety substantiation of 

18 the finished product beyond the safety substan19 tiation of individual ingredients and consider20 ation of the combination of ingredients. 

21 ‘‘(2) STATEMENT OF AN EXPERT MEDICAL OR

22 SCIENTIFIC BODY.—For purposes of this section, a 

23 statement of an expert medical or scientific body is 

24 an official statement of that body, if— 


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1 ‘‘(A) the medical or scientific body is a 

2 Federal, State, national, or international entity 

3 with recognized expertise in chemical or cos4 metic safety, or other similarly recognized body 

5 composed of scientific and medical experts; 

6 ‘‘(B) the statement is based upon adequate 

7 data to support the finding of safety, and such 

8 data are available to the Food and Drug Ad9 ministration; and 

10 ‘‘(C) the statement is published and en11 dorsed by the medical or scientific body and is 

12 not a statement of an employee of such body 

13 made in the individual capacity of the employee. 

14 ‘‘(c) REBUTTAL OF PRESUMPTION.—Notwith15 standing subsection (b), a determination under subsection 

16 (a) will not be presumed to be based on adequate evidence 

17 if— 

18 ‘‘(1) the Food and Drug Administration issues 

19 an order under section 608 that an ingredient or 

20 non-functional constituent in the finished product is 

21 not safe under the product’s conditions of use or 

22 customary or usual use; or 

23 ‘‘(2) the Food and Drug Administration has 

24 provided the manufacturer with notice that— 


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1 ‘‘(A) the manufacturer has not met the cri2 teria under subsection (b); or 

3 ‘‘(B) the Food and Drug Administration 

4 has information that raises significant questions 

5 about the safety of the product or any of its in6 gredients. 

7 ‘‘(d) TIMELY UPDATE.—Upon notice of inadequate 

8 evidence under subsection (c), the responsible person shall 

9 have 10 days to submit additional evidence to the Food 

10 and Drug Administration regarding the safety of an ingre11 dient, non-functional constituent, or the entire cosmetic 

12 product, and the Food and Drug Administration shall 

13 have 30 days from the date of receipt of such additional 

14 evidence to provide the responsible person with notice that 

15 the criteria under subsection (b) have been met or not met. 

16 ‘‘(e) RECORDS MAINTENANCE.—The responsible per17 son shall maintain records documenting the determination 

18 required under this section and the information on which 

19 it is based until 5 years after the finished product is no 

20 longer marketed. 

21 ‘‘(f) SUBMISSION OF RECORDS.— 

22 ‘‘(1) IN GENERAL.—The records required under 

23 subsection (e) shall, upon the written request of the 

24 Food and Drug Administration to the responsible 

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1 tration within a reasonable timeframe not to exceed 

2 60 days, in either electronic or paper form. 

3 ‘‘(2) CRITERIA.—The Food and Drug Adminis4 tration may require records under paragraph (1) 

5 if— 

6 ‘‘(A) the Food and Drug Administration 

7 has a reasonable belief, described in written no8 tice, that— 

9 ‘‘(i) the finished product may be 

10 harmful based on adverse event reports or 

11 other scientific information; 

12 ‘‘(ii) scientific information raises cred13 ible and relevant questions about the safe14 ty of the product or any of its ingredients; 

15 ‘‘(iii) the responsible person has not 

16 made the determination required under 

17 subsection (a), or such determination is 

18 not supported by adequate evidence; or 

19 ‘‘(iv) one or more of the criteria to es20 tablish a presumption of adequate evidence 

21 of safety in subsection (b) has not been 

22 satisfied; 

23 ‘‘(B) the Food and Drug Administration, 

24 an expert regulatory body, or an expert body 

25 composed of scientific and medical experts finds 


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1 an ingredient in the product to be unsafe under 

2 the conditions of use of the product; or 

3 ‘‘(C) the Food and Drug Administration 

4 concludes that submission of the records will 

5 serve the public health or otherwise enable the 

6 Food and Drug Administration to fulfill the 

7 cosmetic safety purposes of this section. 

8 ‘‘(g) GUIDANCE AND REGULATIONS.— 

9 ‘‘(1) IN GENERAL.—The Food and Drug Ad10 ministration shall issue guidance describing the evi11 dence necessary to support a determination under 

12 subsection (a), and may, by regulation, establish ex13 emptions to the requirements of this section, if the 

14 Food and Drug Administration determines that such 

15 exemptions are supported by adequate evidence and 

16 would have no adverse effect on public health. 

17 ‘‘(2) SMALL BUSINESSES.—The Food and Drug 

18 Administration shall, after consultation with the 

19 Small Business Administration and small businesses 

20 that manufacture cosmetics, provide additional guid21 ance for small businesses on compliance with the re22 quirements of this section. Such guidance shall in23 clude specific examples of options for compliance 

24 that do not place an undue burden on small busi25 nesses.’’. 


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1 (b) EFFECTIVE DATE.—Section 609 of the Federal 

2 Food, Drug, and Cosmetic Act, as added by subsection 

3 (a), shall take effect 180 days after the date of enactment 

4 of this Act. 

5 SEC. 103. GOOD MANUFACTURING PRACTICES FOR COS6 METICS. 

7 (a) IN GENERAL.—Chapter VI of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

9 amended by section 102, is further amended by adding 

10 at the end the following: 

11 ‘‘SEC. 610. GOOD MANUFACTURING PRACTICES FOR COS12 METICS. 

13 ‘‘(a) IN GENERAL.—The Food and Drug Administra14 tion shall review national and international standards for 

15 cosmetic good manufacturing practices that are in exist16 ence on the date of enactment of the Personal Care Prod17 ucts Safety Act and shall develop and implement, through 

18 regulations, United States standards consistent, to the ex19 tent the Food and Drug Administration determines prac20 ticable and appropriate, with such national and inter21 national standards for cosmetic good manufacturing prac22 tices to ensure that requirements of this chapter with re23 spect to the manufacture of cosmetic products are in har24 mony. 


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1 ‘‘(b) TIMEFRAME.—The Food and Drug Administra2 tion shall publish a proposed rule described in subsection 

3 (a) not later than 18 months after the date of enactment 

4 of the Personal Care Products Safety Act and shall pub5 lish a final such rule not later than 3 years after such 

6 date of enactment.’’. 

7 (b) EFFECTIVE DATE FOR COSMETIC MANUFACTUR8 ERS.— 

9 (1) LARGE BUSINESSES.—For businesses of a 

10 size greater than the Small Business Administra11 tion’s standard for a small business, section 610 of 

12 the Federal Food, Drug, and Cosmetic Act (as 

13 added by subsection (a)) shall take effect beginning 

14 180 days after the date on which the Food and 

15 Drug Administration makes effective cosmetic good 

16 manufacturing practices. 

17 (2) SMALL BUSINESSES.—For businesses of a 

18 size that meets the Small Business Administration’s 

19 standard for a small business, section 610 of the 

20 Federal Food, Drug, and Cosmetic Act (as added by 

21 subsection (a)) shall take effect beginning 2 years 

22 after the date the Food and Drug Administration 

23 makes effective cosmetic good manufacturing prac24 tices. 


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1 (c) ENFORCEMENT.—Section 601 of Chapter VI of 

2 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 361) is amended by adding at the end the following: 

4 ‘‘(f) If the methods used in, or the facilities or con5 trols used for, its manufacture, processing, packing, or 

6 holding do not conform to current good manufacturing 

7 practice, as prescribed by the Food and Drug Administra8 tion.’’. 

9 SEC. 104. ADVERSE EVENT REPORTS. 

10 Chapter VI of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 361 et seq.), as amended by section 

12 103(a), is further amended by adding at the end the fol13 lowing: 

14 ‘‘SEC. 611. ADVERSE EVENT REPORTING FOR COSMETICS. 

15 ‘‘(a) IN GENERAL.—With respect to any cosmetic 

16 product distributed in the United States, the responsible 

17 person shall submit to the Food and Drug Administration 

18 a report of any serious adverse event associated with such 

19 cosmetic product, when used in the United States, accom20 panied by a copy of the label on or with the retail pack21 aging of the cosmetic, any new medical information, re22 lated to a submitted serious adverse event report that is 

23 received by the responsible person, and an annual report 

24 for all adverse events received by the responsible person. 

25 ‘‘(b) DEFINITIONS.—In this section: 


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1 ‘‘(1) An ‘adverse event’ for a cosmetic product 

2 is a health-related event associated with the use of 

3 this product that is adverse. 

4 ‘‘(2) A ‘serious adverse event’ for a cosmetic 

5 product is an adverse event that— 

6 ‘‘(A) results in— 

7 ‘‘(i) death; 

8 ‘‘(ii) a life-threatening experience; 

9 ‘‘(iii) inpatient hospitalization; 

10 ‘‘(iv) a persistent or significant dis11 ability or incapacity; 

12 ‘‘(v) congenital anomaly or birth de13 fect; or 

14 ‘‘(vi) significant disfigurement, includ15 ing serious and persistent rashes and infec16 tions; or 

17 ‘‘(B) requires, based on appropriate med18 ical judgment, a medical or surgical interven19 tion to prevent an outcome described in sub20 paragraph (A). 

21 ‘‘(c) SUBMISSION OF REPORTS.— 

22 ‘‘(1) SERIOUS ADVERSE EVENT REPORTS.—Ex23 cept as provided in paragraph (2), the responsible 

24 person shall submit a serious adverse event report to 

25 the Food and Drug Administration not later than 15 


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1 business days after information concerning the ad2 verse event is received. If a serious adverse event re3 port for a cosmetic with drug properties is filed 

4 using Form FDA 3500A (or any successor form de5 veloped for such purpose) or its electronic equivalent 

6 for over-the-counter drugs, the responsible person 

7 shall not have to submit a duplicative serious ad8 verse event report under this section. 

9 ‘‘(2) NEW MEDICAL INFORMATION.—The re10 sponsible person shall submit to the Food and Drug 

11 Administration any new medical information, related 

12 to a submitted serious adverse event report that is 

13 received by the responsible person within 1 year of 

14 the initial report, and shall submit such information 

15 not later than 15 business days after the new infor16 mation is received by the responsible person. 

17 ‘‘(3) ANNUAL REPORT.— 

18 ‘‘(A) IN GENERAL.—Not later than March 

19 1 of each year, the responsible person shall sub20 mit an electronic report for the prior calendar 

21 year for each cosmetic product marketed during 

22 that year. 

23 ‘‘(B) CONTENTS.—Each report under this 

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1 riod, a complete list of individual reports, and 

2 an estimate of the total number of product 

3 units estimated to have been distributed to con4 sumers during such period. The report shall not 

5 include consumer complaints that are solely re6 garding efficacy and do not contain any infor7 mation about an adverse event. The Food and 

8 Drug Administration shall further specify the 

9 contents of the annual electronic report by reg10 ulation or guidance. 

11 ‘‘(4) EXEMPTION.—The Food and Drug Ad12 ministration may establish by regulation an exemp13 tion to any of the requirements under this sub14 section if the Food and Drug Administration deter15 mines that such exemption is supported by adequate 

16 evidence and would have no adverse effect on public 

17 health. 

18 ‘‘(d) REQUIREMENTS.— 

19 ‘‘(1) IN GENERAL.—Each serious adverse event 

20 report under this section shall be submitted to the 

21 Food and Drug Administration using an electronic 

22 system of the Food and Drug Administration. The 

23 Food and Drug Administration shall make such elec24 tronic system available not later than 1 year after 


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1 the date of enactment of the Personal Care Products 

2 Safety Act. 

3 ‘‘(2) MODIFICATION.—The format of the re4 porting system may be modified by the Food and 

5 Drug Administration and the reports may include 

6 additional information. The Food and Drug Admin7 istration may, in guidance, further specify the for8 mat and contents of required reports. 

9 ‘‘(3) SCOPE OF SERIOUS ADVERSE EVENT RE10 PORT.—A serious adverse event report (including all 

11 information submitted in the initial report or added 

12 later) submitted to the Food and Drug Administra13 tion under subsection (a) includes— 

14 ‘‘(A) a report under section 756 with re15 spect to safety and related to a specific cos16 metic product; 

17 ‘‘(B) a record about an individual who suf18 fered the serious adverse event under section 

19 552a of title 5, United States Code; 

20 ‘‘(C) a medical or similar file documenting 

21 the serious adverse event, the disclosure of 

22 which would constitute a violation of section 

23 552(b)(6) of such title 5, and shall not be pub24 licly disclosed unless all personally identifiable 

25 information is redacted; and 


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1 ‘‘(D) contact information for the individual 

2 reporting the serious adverse event. 

3 ‘‘(4) RESPONSIBILITY TO GATHER INFORMA4 TION.—After an individual initiates the reporting of 

5 a serious adverse event, the responsible person for 

6 the cosmetic product shall actively gather all of the 

7 information to complete and file the report with the 

8 Food and Drug Administration. 

9 ‘‘(5) NO ADVERSE EVENTS TO REPORT.—The 

10 Food and Drug Administration shall provide an op11 tion as part of the electronic registration process for 

12 the responsible person to indicate if such responsible 

13 person had no adverse events to report over the pre14 vious year. With respect to a responsible person who 

15 received no adverse event reports for a year, the an16 nual adverse event report requirement may be met 

17 by indicating no such events on the annual registra18 tion form. 

19 ‘‘(e) LIMITATION WITH RESPECT TO ADVERSE

20 EVENT REPORTS.—The submission of an adverse event 

21 report in compliance with subsection (a) shall not con22 stitute an admission that the cosmetic involved caused or 

23 contributed to the adverse event. 

24 ‘‘(f) CONTACT INFORMATION.—The label of a cos25 metic shall bear the domestic telephone number or elecVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 tronic contact information, and it is encouraged that the 

2 label include both the telephone number and electronic 

3 contact information, through which the responsible person 

4 may receive a report of an adverse event. 

5 ‘‘(g) MAINTENANCE OF RECORDS.—The responsible 

6 person shall maintain records related to each report of an 

7 adverse event received by the responsible person for a pe8 riod of 6 years. 

9 ‘‘(h) AVAILABILITY TO STATES.—The Food and 

10 Drug Administration shall make available records sub11 mitted under this section to any State, upon request. In12 formation disclosed to a State that is exempt from disclo13 sure under section 552(b)(4) of title 5, United States 

14 Code, shall be treated as a trade secret and confidential 

15 information by the State. 

16 ‘‘(i) EFFECTIVE DATE OF REQUIREMENT WITH RE17 SPECT TO SERIOUS ADVERSE EVENTS.—The requirement 

18 under this section to report serious adverse events shall 

19 become effective on the date that the Food and Drug Ad20 ministration publicizes the availability of the electronic 

21 system described in subsection (d)(1).’’. 


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1 SEC. 105. RECORDS INSPECTION; MANDATORY RECALL AU2 THORITY. 

3 Chapter VI of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 361 et seq.), as amended by section 104, 

5 is further amended by adding at the end the following: 

6 ‘‘SEC. 612. INSPECTION OF COSMETIC RECORDS. 

7 ‘‘(a) INSPECTION OF RECORDS.—Each manufac8 turer, processor, packer, or holder of a cosmetic shall, at 

9 the request of an officer or employee duly designated by 

10 the Food and Drug Administration, permit such officer 

11 or employee, upon presentation of appropriate credentials 

12 and written notice to such person, at reasonable times and 

13 within reasonable limits and in a reasonable manner, to 

14 have access to and copy— 

15 ‘‘(1) all records maintained under section 611 

16 and in accordance with the rules promulgated by the 

17 Food and Drug Administration under section 610, 

18 as applicable; and 

19 ‘‘(2) except as provided in subsection (b), all 

20 other records, if the Food and Drug Administra21 tion— 

22 ‘‘(A) has a reasonable belief that the cos23 metic— 

24 ‘‘(i) is adulterated; 

25 ‘‘(ii) has caused a reportable serious 

26 adverse event; or 


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1 ‘‘(iii) contains an ingredient that sub2 stantial new scientific information shows 

3 may be unsafe when present in a cosmetic; 

4 and 

5 ‘‘(B) provides written notice of the basis 

6 for the Food and Drug Administration’s rea7 sonable belief described in subparagraph (A). 

8 ‘‘(b) EXCLUSIONS.—No inspection authorized by this 

9 section shall extend to financial data, pricing data, per10 sonnel data (other than data as to qualification of tech11 nical and professional personnel performing functions sub12 ject to this Act), research data (other than safety data) 

13 or sales data other than shipment data. 

14 ‘‘(c) SCOPE.—The requirements under subsection (a) 

15 apply to records maintained by or on behalf of such person 

16 in any format (including paper and electronic formats) 

17 and at any location. 

18 ‘‘(d) PROTECTION OF SENSITIVE INFORMATION.— 

19 The Food and Drug Administration shall take appropriate 

20 measures to ensure that there are effective procedures to 

21 prevent the unauthorized disclosure of any trade secret or 

22 confidential information that is obtained by the Food and 

23 Drug Administration pursuant to this section. Information 

24 disclosed to a State that is exempt from disclosure under 

25 section 552(b)(4) of title 5, United States Code, shall be 


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1 treated as a trade secret and confidential information by 

2 the State. 

3 ‘‘(e) LIMITATIONS.—This section shall not be con4 strued— 

5 ‘‘(1) to limit the authority of the Food and 

6 Drug Administration to inspect records or to require 

7 establishment and maintenance of records under any 

8 other provision of this Act; or 

9 ‘‘(2) to have any legal effect on section 552 of 

10 title 5, United States Code, or section 1905 of title 

11 18, United States Code.’’. 

12 ‘‘SEC. 613. MANDATORY RECALL AUTHORITY. 

13 ‘‘(a) VOLUNTARY PROCEDURES.—If the Food and 

14 Drug Administration determines that there is a reasonable 

15 probability that a cosmetic is adulterated under section 

16 601 or misbranded under section 602 and the use of or 

17 exposure to such cosmetic is likely to cause serious adverse 

18 health consequences or death, the Food and Drug Admin19 istration shall provide the responsible person with an op20 portunity to voluntarily cease distribution and recall such 

21 article. 

22 ‘‘(b) PREHEARING ORDER TO MANDATORILY CEASE

23 DISTRIBUTION AND GIVE NOTICE.— 

24 ‘‘(1) IN GENERAL.—If the responsible person 

25 refuses to or does not voluntarily cease distribution 


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1 or recall such cosmetic within the time and in the 

2 manner prescribed by the Food and Drug Adminis3 tration, the Food and Drug Administration may 

4 order such person to— 

5 ‘‘(A) immediately cease distribution of 

6 such cosmetic; and 

7 ‘‘(B) as applicable, immediately notify all 

8 persons— 

9 ‘‘(i) manufacturing, processing, pack10 ing, transporting, holding, receiving, dis11 tributing, or importing and selling such 

12 cosmetic; and 

13 ‘‘(ii) to which such cosmetic has been 

14 distributed, transported, or sold, 

15 to immediately cease distribution of such cos16 metic. 

17 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

18 ‘‘(A) IN GENERAL.—If a cosmetic covered 

19 by a recall order issued under paragraph (1)(B) 

20 has been distributed to a warehouse-based third 

21 party logistics provider without providing such 

22 provider sufficient information to know or rea23 sonably determine the precise identity of such 

24 cosmetic covered by a recall order that is in its 

25 possession, the notice provided by the responVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 sible person subject to the order issued under 

2 paragraph (1)(B) shall include such information 

3 as is necessary for the warehouse-based third 

4 party logistics provider to identify the cosmetic. 

5 ‘‘(B) RULES OF CONSTRUCTION.—Nothing 

6 in this paragraph shall be construed— 

7 ‘‘(i) to exempt a warehouse-based 

8 third party logistics provider from the re9 quirements of this chapter, including the 

10 requirements of this section and section 

11 612; or 

12 ‘‘(ii) to exempt a warehouse-based 

13 third party logistics provider from being 

14 the subject of a mandatory recall order. 

15 ‘‘(3) DETERMINATION TO LIMIT AREAS AF16 FECTED.—If the Food and Drug Administration re17 quires a responsible person to cease distribution 

18 under paragraph (1)(A) of a cosmetic, the Food and 

19 Drug Administration may limit the size of the geo20 graphic area and the markets affected by such ces21 sation if such limitation would not compromise the 

22 public health. 

23 ‘‘(c) HEARING ON ORDER.—The Food and Drug Ad24 ministration shall provide the responsible party subject to 

25 an order under subsection (b) with an opportunity for an 


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1 informal hearing, to be held as soon as possible, but not 

2 later than 2 days after the issuance of the order, on the 

3 actions required by the order and on why the cosmetic that 

4 is the subject of the order should not be recalled. 

5 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA6 TION OF ORDER.— 

7 ‘‘(1) AMENDMENT OF ORDER.—If, after pro8 viding opportunity for an informal hearing under 

9 subsection (c), the Food and Drug Administration 

10 determines that removal of the cosmetic from com11 merce is necessary, the Food and Drug Administra12 tion shall, as appropriate— 

13 ‘‘(A) amend the order to require recall of 

14 such cosmetic or other appropriate action; 

15 ‘‘(B) specify a timetable in which the recall 

16 shall occur; 

17 ‘‘(C) require periodic reports to the Food 

18 and Drug Administration describing the 

19 progress of the recall; and 

20 ‘‘(D) provide notice to consumers to whom 

21 such cosmetic was, or may have been, distrib22 uted. 

23 ‘‘(2) VACATING OF ORDER.—If, after such hear24 ing, the Food and Drug Administration determines 

25 that adequate grounds do not exist to continue the 


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1 actions required by the order, or that such actions 

2 should be modified, the Food and Drug Administra3 tion shall vacate the order or modify the order. 

4 ‘‘(e) COOPERATION AND CONSULTATION.—The Food 

5 and Drug Administration shall work with State and local 

6 public health officials in carrying out this section, as ap7 propriate. 

8 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 

9 under this section, the Food and Drug Administration 

10 shall— 

11 ‘‘(1) ensure that a press release is published re12 garding the recall, and that alerts and public notices 

13 are issued, as appropriate, in order to provide notifi14 cation— 

15 ‘‘(A) of the recall to consumers and retail16 ers to whom such cosmetic was, or may have 

17 been, distributed; and 

18 ‘‘(B) that includes, at a minimum— 

19 ‘‘(i) the name of the cosmetic subject 

20 to the recall; 

21 ‘‘(ii) a description of the risk associ22 ated with such article; and 

23 ‘‘(iii) to the extent practicable, infor24 mation for consumers about similar cosVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 metics that are not affected by the recall; 

2 and 

3 ‘‘(2) ensure publication on the Internet website 

4 of the Food and Drug Administration an image of 

5 the cosmetic that is the subject of the press release 

6 described in paragraph (1), if available. 

7 ‘‘(g) NO DELEGATION.—The authority conferred by 

8 this section to order a recall or vacate a recall order shall 

9 not be delegated to any officer or employee other than the 

10 Commissioner. 

11 ‘‘(h) EFFECT.—Nothing in this section shall affect 

12 the authority of the Food and Drug Administration to re13 quest or participate in a voluntary recall, or to issue an 

14 order to cease distribution or to recall under any other 

15 provision of this chapter or under the Public Health Serv16 ice Act.’’. 

17 SEC. 106. LABELING. 

18 (a) IN GENERAL.—Chapter VI of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 361 et seq.), as 

20 amended by section 105, is further amended by adding 

21 at the end the following: 

22 ‘‘SEC. 614. LABELING. 

23 ‘‘(a) SAFETY REVIEW AND LABELING.—Following a 

24 review of cosmetic ingredients that determines that warn25 ings are required to help ensure safe use of cosmetic prodVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00060 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 ucts under section 608(d)(5), the Food and Drug Admin2 istration shall require labeling of cosmetics that are not 

3 appropriate for use in the entire population, including 

4 warnings that vulnerable populations, such as children or 

5 pregnant women, should limit or avoid using the product. 

6 ‘‘(b) COSMETIC PRODUCTS FOR PROFESSIONAL

7 USE.— 

8 ‘‘(1) DEFINITION OF PROFESSIONAL.—With re9 spect to cosmetics, the term ‘professional’ means an 

10 individual who— 

11 ‘‘(A) is licensed by an official State author12 ity to practice in the field of cosmetology, nail 

13 care, barbering, and or esthetics; 

14 ‘‘(B) has complied with all requirements 

15 set forth by the State for such licensing; and 

16 ‘‘(C) has been granted a license by a State 

17 board or legal agency or legal authority. 

18 ‘‘(2) LISTING OF INGREDIENTS.—Cosmetic 

19 products used and sold by professionals shall list all 

20 ingredients, as required for other cosmetic products 

21 under this chapter. 

22 ‘‘(3) PROFESSIONAL USE LABELING.—In the 

23 case of a cosmetic product intended to be used only 

24 by a professional on account of a specific ingredient 

25 or increased concentration of an ingredient that reVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 quires safe handling by trained professionals, the 

2 product shall bear a statement as follows: ‘To be Ad3 ministered Only by Licensed Professionals’. 

4 ‘‘(c) DISPLAY.—The warning required under sub5 section (a) and the statement required under subsection 

6 (b)(3) shall be prominently displayed— 

7 ‘‘(1) in the primary language used on the label; 

8 and 

9 ‘‘(2) in conspicuous and legible type in contrast 

10 by typography, layout, or color with other material 

11 printed or displayed on the label. 

12 ‘‘(d) INTERNET SALES.—In the case of Internet sales 

13 of cosmetics, each Internet website offering cosmetic prod14 ucts for sale to consumers shall provide the same informa15 tion that is included on the packaging of the cosmetic 

16 products as regularly available, and the warnings and 

17 statements described in subsection (c) shall be promi18 nently and conspicuously displayed on the website. 

19 ‘‘(e) CONTACT INFORMATION.—The label on each 

20 cosmetic shall bear the domestic telephone number or elec21 tronic contact information, and it is encouraged that the 

22 label include both the telephone number and electronic 

23 contact information, that consumers may use to contact 

24 the responsible person with respect to adverse events. The 

25 contact number shall provide a means for consumers to 


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1 obtain additional information about ingredients in a cos2 metic, including the ability to ask if a specific ingredient 

3 may be present that is not listed on the label, including 

4 whether a specific ingredient may be contained in the fra5 grance or flavor used in the cosmetic. The manufacturer 

6 of the cosmetic is responsible for providing such informa7 tion, including obtaining the information from suppliers 

8 if it is not readily available. Suppliers are required to re9 lease such information upon request of the cosmetic manu10 facturer.’’. 

11 (b) EFFECTIVE DATE.—Section 614 of the Federal 

12 Food, Drug, and Cosmetic Act, as added by subsection 

13 (a), shall take effect on the date that is 1 year after the 

14 date of enactment of this Act. 

15 SEC. 107. COAL TAR CHEMICALS. 

16 Chapter VI of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 361 et seq.), as amended by section 106, 

18 is further amended by adding at the end the following: 

19 ‘‘SEC. 615. COAL TAR CHEMICALS. 

20 ‘‘(a) IN GENERAL.—Under section 608, the Food and 

21 Drug Administration may review any cosmetic ingredient 

22 in order to determine if it is safe in cosmetic products 

23 without the need for specified conditions of use or toler24 ances, safe in cosmetic products under specified conditions 

25 of use or tolerances, or not safe in cosmetic products. 


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1 ‘‘(b) COAL TAR HAIR DYES.—Specific chemicals in 

2 coal tar hair dyes may be selected and reviewed under sec3 tion 608(a)(3).’’. 

4 SEC. 108. ANIMAL TESTING ALTERNATIVES. 

5 Chapter VI of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 361 et seq.), as amended by section 107, 

7 is further amended by adding the following: 

8 ‘‘SEC. 616. ANIMAL TESTING ALTERNATIVES. 

9 ‘‘(a) IN GENERAL.—To minimize the use of animal 

10 testing for safety of cosmetic ingredients, non-functional 

11 constituents, and finished cosmetic products, the Food 

12 and Drug Administration shall— 

13 ‘‘(1) encourage the use of alternative testing 

14 methods that provide information that is equivalent 

15 or superior in scientific quality to the animal testing 

16 method to— 

17 ‘‘(A) not involve the use of an animal to 

18 test a chemical substance for safe use in cos19 metics; or 

20 ‘‘(B) use fewer animals than conventional 

21 animal-based tests for safe use in cosmetics 

22 when nonanimal methods are impracticable; and 

23 ‘‘(2) encourage— 

24 ‘‘(A) the sharing of data across companies 

25 and organizations that are testing for safety in 


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1 cosmetics, so as to avoid duplication of animal 

2 tests; and 

3 ‘‘(B) funding for research and validation of 

4 alternative testing methods. 

5 ‘‘(b) GUIDANCE.—Not later than 3 years after the 

6 date of enactment of the Personal Care Products Safety 

7 Act, the Food and Drug Administration shall issue guid8 ance on the acceptability of scientifically reliable and rel9 evant alternatives to animal testing for the safety of cos10 metic ingredients, non-functional constituents, and fin11 ished cosmetic products, and encouraging the use of such 

12 methods. The Food and Drug Administration shall update 

13 such guidance on an annual basis. 

14 ‘‘(c) RESOURCES REGARDING ANIMAL TESTING AL15 TERNATIVES.—Not later than 180 days after the date of 

16 enactment of the Personal Care Products Safety Act, the 

17 Food and Drug Administration shall provide information 

18 on the Internet website of the Food and Drug Administra19 tion regarding resources available for information about 

20 non-animal methods, and methods that reduce animal 

21 usage, in testing for the safety of cosmetic ingredients, 

22 non-functional constituents, and finished cosmetic prod23 ucts.’’. 


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1 SEC. 109. PREEMPTION. 

2 Chapter VI of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 361 et seq.), as amended by section 108, 

4 is further amended by adding the following: 

5 ‘‘SEC. 617. PREEMPTION. 

6 ‘‘(a) REGISTRATION, GOOD MANUFACTURING PRAC7 TICES, RECALLS, ADVERSE EVENT REPORTING.—Except 

8 for a State requirement that is in full effect and imple9 mented on the date of enactment of the Personal Care 

10 Products Safety Act, no State or political subdivision of 

11 a State may establish or continue in effect any require12 ment for cosmetics with respect to registration, good man13 ufacturing practices, mandatory recalls, or adverse event 

14 reporting. 

15 ‘‘(b) SAFETY OF COSMETIC INGREDIENTS AND NON16 FUNCTIONAL CONSTITUENTS.— 

17 ‘‘(1) IN GENERAL.—Except for a State require18 ment that is more restrictive than a final order 

19 issued under section 608(d)(3) and that is in full ef20 fect and implemented on the date of enactment of 

21 the Personal Care Products Safety Act, no State or 

22 political subdivision of a State may establish or con23 tinue in effect any requirement with respect to the 

24 safety of a cosmetic ingredient or non-functional 

25 constituent that is the subject of a final order under 


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1 section 608(d)(3) that is different from, or in addi2 tion to, a final order issued under section 608(d)(3). 

3 ‘‘(2) DELAYED EFFECT OF NEW STATE RE4 QUIREMENTS.—From the date that the Food and 

5 Drug Administration has made public the final selec6 tion of a cosmetic ingredient or non-functional con7 stituent to be reviewed in the coming year under sec8 tion 608(a)(3)(B), and opened the public comment 

9 period under section 608(a)(2), until the date that 

10 is one year after the Food and Drug Administration 

11 has made public such selection, no State or political 

12 subdivision of a State may establish any new re13 quirement related to such cosmetic ingredient or 

14 non-functional constituent. 

15 ‘‘(3) SCOPE.—This subsection shall not be con16 strued to modify or affect the authority of a State 

17 or political subdivision of a State with respect to 

18 such safety requirements unrelated to the scope of 

19 the safety assessment under section 608. 

20 ‘‘(4) SENSE OF CONGRESS.—It is the sense of 

21 Congress that a State or political subdivision that 

22 regulates the safety of cosmetics with respect to the 

23 health of humans beyond the scope of section 608 

24 should utilize the safety assessment criteria de25 scribed in section 608(h). 


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1 ‘‘(c) STATE REQUIREMENT THAT IS IN FULL EF2 FECT AND IMPLEMENTED.—For purposes of this section: 

3 ‘‘(1) STATE REQUIREMENT.—A State require4 ment includes a State requirement that is adopted 

5 by a State public initiative or referendum. 

6 ‘‘(2) FULL EFFECT AND IMPLEMENTED.—The 

7 term ‘full effect and implemented’ includes require8 ments of States that are implemented after the date 

9 of enactment of the Personal Care Products Safety 

10 Act, if such requirements are under a law that was 

11 in effect, or a lawful program that was established 

12 and functioning, prior to the date of enactment of 

13 the Personal Care Products Safety Act. 

14 ‘‘(d) RULE OF CONSTRUCTION REGARDING PRODUCT

15 LIABILITY.—Notwithstanding any other provision of this 

16 Act, no provision of this chapter relating to a cosmetic 

17 shall be construed to modify or otherwise affect any action 

18 or the liability of any person under State or Federal com19 mon law. 

20 ‘‘(e) LIMITATION.—The Personal Care Products 

21 Safety Act, including the amendments made by such Act, 

22 shall not be construed to preempt any State statute, public 

23 initiative, referendum, or common law, except as expressly 

24 provided in this section.’’. 


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1 SEC. 110. REPORTING. 

2 Chapter VI of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 361 et seq.), as amended by section 109, 

4 is further amended by adding at the end the following: 

5 ‘‘SEC. 618. REPORTING. 

6 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

7 year 2016, and not later than 60 days prior to the end 

8 of each fiscal year for which fees are collected under sec9 tion 744L, the Food and Drug Administration shall pre10 pare and submit to Congress a report concerning the 

11 progress of the Food and Drug Administration in achiev12 ing the objectives of the Personal Care Products Safety 

13 Act during such fiscal year and the future plans of the 

14 Food and Drug Administration for meeting the objectives. 

15 The annual report for a fiscal year shall include— 

16 ‘‘(1) the number of registered facilities and cos17 metic ingredient statements on file with the Food 

18 and Drug Administration; 

19 ‘‘(2) identification of the cosmetic ingredients 

20 and non-functional constituents that have been fully 

21 reviewed for safety by the Food and Drug Adminis22 tration in the prior fiscal year and for which a final 

23 administrative order has been released; 

24 ‘‘(3) identification of at least 5 specific cosmetic 

25 ingredients and non-functional constituents that will 


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1 be reviewed by the Food and Drug Administration 

2 in the next fiscal year; 

3 ‘‘(4) the number of facilities inspected and 

4 mandatory recalls that transpired during that fiscal 

5 year; 

6 ‘‘(5) the number of serious adverse event re7 ports received by the Food and Drug Administration 

8 during that fiscal year; 

9 ‘‘(6) any trends identified by the Food and 

10 Drug Administration about adverse event reports re11 lated to specific cosmetic ingredients or non-func12 tional constituents; and 

13 ‘‘(7) efforts of the Food and Drug Administra14 tion to reduce animal testing for safety of cosmetic 

15 ingredients, non-functional constituents, and cos16 metic products. 

17 ‘‘(b) PUBLIC AVAILABILITY.—The Food and Drug 

18 Administration shall make the reports required under sub19 sections (a) available to the public on the Internet website 

20 of the Food and Drug Administration on the date of sub21 mission of such reports to Congress. 

22 ‘‘(c) PUBLIC INPUT ON SAFETY REVIEW.—Upon re23 lease of the report described in subsection (a), the Food 

24 and Drug Administration shall provide the public with an 

25 opportunity to provide feedback on subsection (a)(3) by— 


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1 ‘‘(1) providing an electronic portal, upon release 

2 of the report, enabling the public to— 

3 ‘‘(A) recommend additional cosmetic ingre4 dients and non-functional constituents to be 

5 considered for review for safety in future years; 

6 and 

7 ‘‘(B) comment on the priorities for the spe8 cific cosmetic ingredients and non-functional 

9 constituents that the Food and Drug Adminis10 tration anticipates will be reviewed in the next 

11 fiscal year; 

12 ‘‘(2) announcing on the Internet website of the 

13 Food and Drug Administration, within the first 30 

14 days of the new fiscal year, any amendments to sub15 section (a)(3) based on public input, pursuant to 

16 paragraph (1); and 

17 ‘‘(3) together with the final announcement of 5 

18 specific cosmetic ingredients and non-functional con19 stituents that will be reviewed in the coming year 

20 under subsection (a)(3), providing a comment period 

21 for further public input, pursuant to section 

22 608(a)(2).’’. 


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1 SEC. 111. SMALL BUSINESSES. 

2 Chapter VI of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 361 et seq.), as amended by section 110, 

4 is further amended by adding at the end the following: 

5 ‘‘SEC. 619. SMALL BUSINESSES. 

6 ‘‘The Commissioner, in coordination with the Admin7 istrator of the Small Business Administration, shall pro8 vide technical assistance, such as guidance and expertise, 

9 to small businesses regarding compliance with the Per10 sonal Care Products Safety Act, including the amend11 ments made by such Act.’’. 

12 SEC. 112. APPLICABILITY WITH RESPECT TO CERTAIN COS13 METICS. 

14 Chapter VI of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 361 et seq.), as amended by section 111, 

16 is further amended by adding at the end the following: 

17 ‘‘SEC. 620. APPLICABILITY WITH RESPECT TO CERTAIN 

18 COSMETICS. 

19 ‘‘In the case of a cosmetic product or a facility that 

20 is subject to the requirements under this chapter and 

21 chapter V, if any requirement under chapter V with re22 spect to such cosmetic or facility is substantially similar 

23 to a requirement under this chapter, the cosmetic product 

24 or facility shall be deemed to be in compliance with the 

25 applicable requirement under this chapter if such product 

26 or facility is in compliance with such substantially similar 


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1 requirement under chapter V, provided that the product 

2 or facility has not obtained a waiver from the requirement 

3 under chapter V.’’. 

4 SEC. 113. ENFORCEMENT. 

5 (a) PROHIBITED ACTS.—Section 301 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend7 ed— 

8 (1) in subsection (e)— 

9 (A) by striking ‘‘504, 564’’ and inserting 

10 ‘‘504, 564, 611, or 612’’; and 

11 (B) by striking ‘‘519, 564’’ and inserting 

12 ‘‘519, 564, 611,’’; 

13 (2) in subsection (j) by inserting ‘‘607, 608, 

14 610,’’ before ‘‘704’’; 

15 (3) in subsection (ii)— 

16 (A) by striking ‘‘760 or 761)’’ and insert17 ing ‘‘604, 760, or 761)’’; and 

18 (B) by striking ‘‘760 or 761) submitted’’ 

19 and inserting ‘‘611, 760, or 761) submitted’’; 

20 (4) in subsection (xx) by inserting ‘‘or 613’’ 

21 after ‘‘423’’; and 

22 (5) by adding at the end the following: 

23 ‘‘(ddd) The failure to register in accordance with sec24 tion 605, the failure to submit a cosmetic ingredient state25 ment under section 606, the failure to provide any inforVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 mation required by section 605 or 606, or the failure to 

2 update the information required by section 605 or 606, 

3 as required.’’. 

4 (b) ADULTERATION.—Section 601 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 361), as 

6 amended by section 103, is further amended by adding 

7 at the end the following: 

8 ‘‘(g) If it contains, after the date prescribed under 

9 section 608(e), an ingredient that the Food and Drug Ad10 ministration has determined under section 608(d)(4) to be 

11 not safe, or not safe under the conditions of use rec12 ommended or suggested in the label or a non-functional 

13 constituent that the Food and Drug Administration has 

14 determined under section 608(d)(4) to be not safe or not 

15 safe in the amount present in the cosmetic. 

16 ‘‘(h) If it is a cosmetic product for which any require17 ment of section 609 (relating to safety substantiation) is 

18 not met.’’. 

19 (c) MISBRANDING.—Section 602 is amended— 

20 (1) in subsection (b)— 

21 (A) by striking ‘‘and (2)’’ and inserting 

22 ‘‘(2)’’; and 

23 (B) by inserting ‘‘; and (3) a domestic ad24 dress or a domestic telephone number, and it is 

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1 tic address and a domestic telephone number, 

2 through which the responsible person may re3 ceive a report of an adverse event associated 

4 with the use of such cosmetic product’’ after 

5 ‘‘numerical count’’; and 

6 (2) by adding at the end the following: 

7 ‘‘(g) If it has been manufactured, processed, packed, 

8 or held in any factory, warehouse, or establishment and 

9 the responsible person, operator, or agent of such factory, 

10 warehouse, or establishment delays, denies, or limits an 

11 inspection, or refuses to permit entry or inspection. 

12 ‘‘(h) If its labeling does not conform with a require13 ment under section 614.’’. 

14 (d) GUIDANCE.—Not later than 1 year after the date 

15 of enactment of this Act, the Food and Drug Administra16 tion shall issue guidance that defines the circumstances 

17 that would constitute delaying, denying, or limiting inspec18 tion, or refusing to permit entry or inspection, for pur19 poses of section 602(g) of the Federal Food, Drug, and 

20 Cosmetic Act, as added by subsection (c)(2). 

21 (e) IMPORTS.—Section 801(a) is amended— 

22 (1) by striking ‘‘section 760 or 761’’ the first, 

23 third, and fourth place such term appears and in24 serting ‘‘section 611, 760, or 761’’; and 


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1 (2) by striking ‘‘760 or 761)’’ and inserting 

2 ‘‘604, 760, or 761)’’. 

3 (f) FACTORY INSPECTION.—Section 704(a)(1) is 

4 amended by inserting after the third sentence the fol5 lowing: ‘‘In the case of any person who manufactures, 

6 processes, packs, holds, distributes, or imports a cosmetic 

7 product, or distributes a cosmetic product and affixes its 

8 name on the cosmetic label, the inspection shall extend 

9 to all records and other information described in section 

10 612 (regarding inspection of cosmetic records), when the 

11 standard for records inspections under paragraph (1) or 

12 (2) of subsection (a) of such section applies, subject to 

13 the limitations under subsection (d) of such section.’’. 

14 SEC. 114. CONSUMER INFORMATION. 

15 The Food and Drug Administration shall post on its 

16 Internet website information for consumers regarding— 

17 (1) final orders regarding the safety of a cos18 metic ingredient or non-functional constituent under 

19 section 608(d)(3); 

20 (2) cosmetic product recalls (including vol21 untary and mandatory recalls); and 

22 (3) identified counterfeit cosmetic products. 


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1 TITLE II—FEES RELATED TO 

2 COSMETIC SAFETY 

3 SEC. 201. FINDINGS. 

4 Congress finds that the fees authorized by the 

5 amendments made by this title will be dedicated to cos6 metic safety activities, as set forth in the goals identified 

7 for purposes of part 10 of subchapter C of chapter VII 

8 of the Federal Food, Drug, and Cosmetic Act, in the let9 ters from the Secretary of Health and Human Services 

10 to the Chairman of the Committee on Health, Education, 

11 Labor, and Pensions of the Senate and the Chairman of 

12 the Committee on Energy and Commerce of the House 

13 of Representatives, as set forth in the Congressional 

14 Record. 

15 SEC. 202. AUTHORITY TO ASSESS AND USE COSMETIC SAFE16 TY FEES. 

17 Subchapter C of chapter VII of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 

19 amended by adding at the end the following: 

20 ‘‘PART 10—FEES RELATING TO COSMETICS 

21 ‘‘SEC. 744L. REGISTRATION FEE. 

22 ‘‘(a) ASSESSMENT AND COLLECTION.— 

23 ‘‘(1) IN GENERAL.—Beginning in fiscal year 

24 2016, the Food and Drug Administration shall as25 sess and collect an annual fee from every responsible 


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1 person (referred to in this section as a ‘registrant’) 

2 who owns or operates any cosmetic facility engaged 

3 in manufacturing or processing, or whose name and 

4 address appear on the label of a cosmetic product 

5 distributed in the United States, except that this 

6 subsection shall not apply to entities described in 

7 subparagraphs (A) through (H) of section 604(3). 

8 ‘‘(2) PAYABLE DATE.—A fee under this section 

9 shall be payable during the period of initial registra10 tion and on the date of registration each year there11 after as prescribed in section 605(a)(1). 

12 ‘‘(b) DEFINITIONS.—In this section: 

13 ‘‘(1) ADJUSTMENT FACTOR.—The term ‘adjust14 ment factor’ applicable to a fiscal year means the 

15 Consumer Price Index for all urban consumers (all 

16 items; United States city average) for October of the 

17 preceding fiscal year divided by such index for Octo18 ber 2015. 

19 ‘‘(2) AFFILIATE.—The term ‘affiliate’ means 

20 any business entity that has a relationship with a 

21 second business entity if, directly or indirectly— 

22 ‘‘(A) one business entity controls, or has 

23 power to control, the other business entity; or 

24 ‘‘(B) a third-party controls, or has the 

25 power to control, both of the business entities. 


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1 ‘‘(3) COSMETIC SAFETY ACTIVITIES.—The term 

2 ‘cosmetic safety activities’— 

3 ‘‘(A) means activities related to compliance 

4 by registrants under section 605 with the re5 quirements of this Act with respect to cos6 metics, including— 

7 ‘‘(i) administrative activities, such as 

8 information technology support, human re9 sources, financial management, the admin10 istration and maintenance of the cosmetic 

11 registration system and the cosmetic ingre12 dient statement system under sections 605 

13 and 606, and fee assessment and collection 

14 under this section; and 

15 ‘‘(ii) implementation and enforcement 

16 activities, such as the establishment of 

17 good manufacturing practices, the review 

18 of adverse event reports, inspection plan19 ning and inspections, and use of enforce20 ment tools; and 

21 ‘‘(B) includes activities related to imple22 mentation of section 608, regarding the review 

23 of cosmetic ingredients and non-functional con24 stituents. 


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1 ‘‘(4) GROSS ANNUAL SALES.—The term ‘gross 

2 annual sales’ means the average United States gross 

3 annual sales for the previous 3-year period of cos4 metics for a registrant, including the sales of all of 

5 its affiliates, as reported in the registration under 

6 section 605. 

7 ‘‘(c) FEE SETTING AND AMOUNTS.— 

8 ‘‘(1) IN GENERAL.—Subject to subsection (d), 

9 the Food and Drug Administration shall establish 

10 the fees to be collected under this section for each 

11 fiscal year after fiscal year 2016, based on the meth12 odology described in paragraph (3)(B), and shall 

13 publish such fees in a Federal Register notice not 

14 later than 60 days before the beginning of each such 

15 fiscal year. 

16 ‘‘(2) FEE EXEMPTION.—Any registrant whose 

17 average gross annual sales of cosmetic products in 

18 the 3-year period immediately preceding the fiscal 

19 year for which the annual fee will be paid was not 

20 more than $500,000, shall be exempt from registra21 tion fees under this section for that fiscal year. 

22 ‘‘(3) ANNUAL FEE SETTING.— 

23 ‘‘(A) FISCAL YEAR 2016.—For fiscal year 

24 2016, to generate a total estimated revenue 

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1 istration fee under subsection (a) shall be as 

2 follows: 

3 ‘‘(i) TIER I–A.—For a registrant that 

4 has gross annual sales of $5,000,000,000 

5 or more in 2015, $1,100,000. 

6 ‘‘(ii) TIER I–B.—For a registrant that 

7 has gross annual sales of at least 

8 $4,000,000,000 per annum but less than 

9 $5,000,000,000 in 2015, $840,000. 

10 ‘‘(iii) TIER II–A.—For a registrant 

11 that has gross annual sales of at least 

12 $3,000,000,000 per annum but less than 

13 $4,000,000,000 in 2015, $720,000. 

14 ‘‘(iv) TIER II–B.—For a registrant 

15 that has gross annual sales of at least 

16 $2,000,000,000 per annum but less than 

17 $3,000,000,000 in 2015, $600,000. 

18 ‘‘(v) TIER III–A.—For a registrant 

19 that has gross annual sales of at least 

20 $1,000,000,000 per annum but less than 

21 $2,000,000,000 in 2015, $500,000. 

22 ‘‘(vi) TIER III–B.—For a registrant 

23 that has gross annual sales of at least 

24 $500,000,000 per annum but less than 

25 $1,000,000,000 in 2015, $395,000. 


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1 ‘‘(vii) TIER IV–A.—For a registrant 

2 that has gross annual sales of at least 

3 $200,000,000 per annum but less than 

4 $500,000,000 in 2015, $325,000. 

5 ‘‘(viii) TIER IV–B.—For a registrant 

6 that has gross annual sales of at least 

7 $100,000,000 per annum but less than 

8 $200,000,000 in 2015, $275,000. 

9 ‘‘(ix) TIER V–A.—For a registrant 

10 that has gross annual sales of at least 

11 $80,000,000 per annum but less than 

12 $100,000,000 in 2015, $185,000. 

13 ‘‘(x) TIER V–B.—For a registrant that 

14 has gross annual sales of at least 

15 $60,000,000 per annum but less than 

16 $80,000,000 in 2015, $95,000. 

17 ‘‘(xi) TIER VI–A.—For a registrant 

18 that has gross annual sales of at least 

19 $40,000,000 per annum but less than 

20 $60,000,000 in 2015, $15,000. 

21 ‘‘(xii) TIER IV–B.—For a registrant 

22 that has gross annual sales of at least 

23 $20,000,000 per annum but less than 

24 $40,000,000 in 2015, $12,000. 


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1 ‘‘(xiii) TIER VII–A.—For a registrant 

2 that has gross annual sales of at least 

3 $2,500,000 per annum but less than 

4 $20,000,000 in 2015, $500. 

5 ‘‘(xiv) TIER VII–B.—For a registrant 

6 that has gross annual sales of at least 

7 $500,000 per annum but less than 

8 $2,500,000 in 2015, $250. 

9 ‘‘(B) FISCAL YEARS 2017–2022.—For fiscal 

10 years 2017–2022, fees under subsection (a) 

11 shall be established to generate a total esti12 mated revenue amount of $20,600,000, as ad13 justed by subsection (d). Of that amount: 

14 ‘‘(i) TIER I–A.—Registrants that have 

15 gross annual sales of $5,000,000,000 or 

16 more in the fiscal year immediately pre17 ceding the fiscal year in which the annual 

18 fee will be paid, shall be responsible, collec19 tively, for 10.7 percent. 

20 ‘‘(ii) TIER I–B.—Registrants that 

21 have gross annual sales of at least 

22 $4,000,000,000 per annum but less than 

23 $5,000,000,000 in the fiscal year imme24 diately preceding the fiscal year in which 


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1 the annual fee will be paid, shall be re2 sponsible, collectively, for 4.1 percent. 

3 ‘‘(iii) TIER II–A.—Registrants that 

4 have gross annual sales of at least 

5 $3,000,000,000 per annum but less than 

6 $4,000,000,000 in the fiscal year imme7 diately preceding the fiscal year in which 

8 the annual fee will be paid, shall be re9 sponsible, collectively, for 3.5 percent. 

10 ‘‘(iv) TIER II–B.—Registrants that 

11 have gross annual sales of at least 

12 $2,000,000,000 per annum but less than 

13 $3,000,000,000 in the fiscal year imme14 diately preceding the fiscal year in which 

15 the annual fee will be paid, shall be re16 sponsible, collectively, for 2.9 percent. 

17 ‘‘(v) TIER III–A.—Registrants that 

18 have gross annual sales of at least 

19 $1,000,000,000 per annum but less than 

20 $2,000,000,000 in the fiscal year imme21 diately preceding the fiscal year in which 

22 the annual fee will be paid, shall be re23 sponsible, collectively, for 7.3 percent. 

24 ‘‘(vi) TIER III–B.—Registrants that 

25 have gross annual sales of at least 


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1 $500,000,000 per annum but less than 

2 $1,000,000,000 in the fiscal year imme3 diately preceding the fiscal year in which 

4 the annual fee will be paid, shall be re5 sponsible, collectively, for 13.4 percent. 

6 ‘‘(vii) TIER IV–A.—Registrants that 

7 have gross annual sales of at least 

8 $200,000,000 per annum but less than 

9 $500,000,000 in the fiscal year imme10 diately preceding the fiscal year in which 

11 the annual fee will be paid, shall be re12 sponsible, collectively, for 15.8 percent. 

13 ‘‘(viii) TIER IV–B.—Registrants that 

14 have gross annual sales of at least 

15 $100,000,000 per annum but less than 

16 $200,000,000 in the fiscal year imme17 diately preceding the fiscal year in which 

18 the annual fee will be paid, shall be re19 sponsible, collectively, for 13.3 percent. 

20 ‘‘(ix) TIER V–A.—Registrants that 

21 have gross annual sales of at least 

22 $80,000,000 per annum but less than 

23 $100,000,000 in the fiscal year imme24 diately preceding the fiscal year in which 


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1 the annual fee will be paid, shall be re2 sponsible, collectively, for 9 percent. 

3 ‘‘(x) TIER V–B.—Registrants that 

4 have gross annual sales of at least 

5 $60,000,000 per annum but less than 

6 $80,000,000 in the fiscal year immediately 

7 preceding the fiscal year in which the an8 nual fee will be paid, shall be responsible, 

9 collectively, for 6.9 percent. 

10 ‘‘(xi) TIER VI–A.—Registrants that 

11 have gross annual sales of at least 

12 $40,000,000 per annum but less than 

13 $60,000,000 in the fiscal year immediately 

14 preceding the fiscal year in which the an15 nual fee will be paid, shall be responsible, 

16 collectively, for 5.1 percent. 

17 ‘‘(xii) TIER VI–B.—Registrants that 

18 have gross annual sales of at least 

19 $20,000,000 per annum but less than 

20 $40,000,000 in the fiscal year immediately 

21 preceding the fiscal year in which the an22 nual fee will be paid, shall be responsible, 

23 collectively, for 4.4 percent. 

24 ‘‘(xiii) TIER VII–A.—Registrants that 

25 have gross annual sales of at least 


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1 $2,500,000 per annum but less than 

2 $20,000,000 in the fiscal year immediately 

3 preceding the fiscal year in which the an4 nual fee will be paid, shall be responsible, 

5 collectively, for 1.2 percent. 

6 ‘‘(xiv) TIER VII–B.—Registrants that 

7 have gross annual sales of at least 

8 $500,000 per annum but less than 

9 $2,500,000 in the fiscal year immediately 

10 preceding the fiscal year in which the an11 nual fee will be paid, shall be responsible, 

12 collectively, for 2.4 percent, except that no 

13 such registrant shall be responsible for 

14 more than $250 per fiscal year. 

15 ‘‘(d) ADJUSTMENTS.— 

16 ‘‘(1) INFLATION ADJUSTMENT.— 

17 ‘‘(A) IN GENERAL.—For fiscal year 2017 

18 and each subsequent fiscal year, the revenues 

19 and fee amounts under subsection (c)(3)(B) 

20 shall be adjusted by the Food and Drug Admin21 istration in the annual Federal Register notice 

22 establishing fees in subsection (c)(1), by an 

23 amount equal to the sum of— 

24 ‘‘(i) one; 


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1 ‘‘(ii) the average annual percent 

2 change in the cost, per full-time equivalent 

3 position of the Food and Drug Administra4 tion, of all personnel compensation and 

5 benefits paid with respect to such positions 

6 for the first 3 of the preceding 4 fiscal 

7 years for which data are available, multi8 plied by the average proportion of per9 sonnel compensation and benefits costs to 

10 total Food and Drug Administration costs 

11 for the first 3 years of the preceding 4 fis12 cal years for which data are available; and 

13 ‘‘(iii) the average annual percent 

14 change that occurred in the Consumer 

15 Price Index for urban consumers (Wash16 ington-Baltimore, DC6 MD-VA-WV; not 

17 seasonally adjusted; all items less food and 

18 energy; annual index) for the first 3 years 

19 of the preceding 4 years for which data are 

20 available multiplied by the average propor21 tion of all costs other than personnel com22 pensation and benefits costs to total Food 

23 and Drug Administration costs for the 

24 first 3 years of the preceding 4 fiscal years 

25 for which data are available. 


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1 ‘‘(B) COMPOUNDED BASIS.—The adjust2 ment made each fiscal year under this sub3 section shall be added on a compounded basis 

4 to the sum of all adjustments made each fiscal 

5 year after fiscal year 2016 under this sub6 section. 

7 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal 

8 year 2022, the Food and Drug Administration may, 

9 in addition to adjustments under paragraph (1), fur10 ther increase the fee revenues and fees established in 

11 subsection (c) if such an adjustment is necessary to 

12 provide for not more than 3 months of operating re13 serves of carryover fees for cosmetic safety activities 

14 for the first 3 months of fiscal year 2023. If such 

15 an adjustment is necessary, the rationale for the in16 crease, shall be contained in the annual Federal 

17 Register notice establishing fees, in subsection 

18 (c)(1), for fiscal year 2022. If the Food and Drug 

19 Administration has carryover balances for such ac20 tivities in excess of 3 months of such operating re21 serves, the adjustment under this subparagraph 

22 shall not be made. 

23 ‘‘(3) WORKLOAD ADJUSTMENT.— 

24 ‘‘(A) IN GENERAL.—For fiscal year 2017 

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1 nues established in subsection (c)(3)(B) are ad2 justed for a fiscal year for inflation in accord3 ance with paragraph (1), the fee revenues shall 

4 be adjusted further for each fiscal year to re5 flect changes in the workload of the Food and 

6 Drug Administration for actual changes in 

7 workload volume due to the process of reviewing 

8 cosmetic ingredients or non-functional constitu9 ents not listed under section 608(b). 

10 ‘‘(B) DETERMINATION OF ADJUSTMENT.— 

11 The adjustment shall be determined by the 

12 Food and Drug Administration based on the 

13 workload in the most recent 1-year period for 

14 which workload data is available. The Food and 

15 Drug Administration shall publish in the Fed16 eral Register the fee revenues and fees resulting 

17 from the adjustment and the supporting meth18 odologies. 

19 ‘‘(C) MINIMUM REVENUES.—The adjust20 ment shall not result in fee revenues for a fiscal 

21 year that are less than the sum of the amount 

22 under subsection (c)(3)(B), as adjusted for in23 flation under subparagraph (1). 

24 ‘‘(e) LIMITATIONS.— 


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1 ‘‘(1) IN GENERAL.—With respect to the amount 

2 that, under the salaries and expenses account of the 

3 Food and Drug Administration, is appropriated for 

4 a fiscal year for the cosmetics program in the Center 

5 for Food Safety and Applied Nutrition and related 

6 field activities, fees may not be assessed under sub7 section (a) for the fiscal year unless the amount so 

8 appropriated for the fiscal year (excluding the 

9 amount of fees appropriated for the fiscal year), is 

10 equal to or greater than that assessed for fiscal year 

11 2015, multiplied by the adjustment factor applicable 

12 to the fiscal year involved. 

13 ‘‘(2) AUTHORITY.—If the Food and Drug Ad14 ministration does not assess fees under subsection 

15 (a) during any portion of a fiscal year because of 

16 paragraph (1) and if at a later date in such fiscal 

17 year the Food and Drug Administration may assess 

18 such fees, the Food and Drug Administration may 

19 assess and collect such fees, without any modifica20 tion in the rate, for registration under section 605 

21 at any time in such fiscal year. 

22 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

23 ‘‘(1) IN GENERAL.—Fees authorized under sub24 section (a) shall be collected and available for obliga25 tion only to the extent and in the amount provided 


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1 in advance in appropriations Acts. Such fees are au2 thorized to remain available until expended. Such 

3 sums as may be necessary may be transferred from 

4 the Food and Drug Administration salaries and ex5 penses appropriation account without fiscal year lim6 itation to such appropriation account for salaries 

7 and expenses with such fiscal year limitation. The 

8 sums transferred shall be available solely for cos9 metic safety activities. 

10 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

11 ACTS.—The fees authorized by this section— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graphs (C) and (D), the fees authorized by this 

14 section shall be collected and available in each 

15 fiscal year in an amount not to exceed the 

16 amount specified in appropriation Acts, or oth17 erwise made available for obligation for such 

18 fiscal year. 

19 ‘‘(B) USE OF FEES AND LIMITATION.— 

20 The fees authorized by this section shall be col21 lected and available only to defray the costs of 

22 cosmetic safety activities. 

23 ‘‘(C) FEE COLLECTIONS DURING FIRST

24 PROGRAM YEAR.—Until the date of enactment 

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1 tember 30, 2015, for the salaries and expenses 

2 account of the Food and Drug Administration, 

3 fees authorized by this section for fiscal year 

4 2016 may be collected and shall be credited to 

5 such account to remain available until ex6 pended. Fees collected under this subparagraph 

7 shall be considered discretionary for purposes of 

8 the Balanced Budget and Emergency Deficit 

9 Control Act of 1985. 

10 ‘‘(D) REIMBURSEMENT OF START-UP

11 AMOUNTS.—Any amounts allocated to establish 

12 programs under sections 605 and 606, prior to 

13 collection of fees, may be reimbursed through 

14 any appropriated fees collected under this sec15 tion, in such manner as the Food and Drug Ad16 ministration determines appropriate. Any 

17 amounts reimbursed under this subparagraph 

18 shall be available for the programs and activi19 ties for which funds allocated to establish the 

20 programs were available, prior to such alloca21 tion, until the end of the fiscal year in which 

22 the reimbursement occurs, notwithstanding any 

23 otherwise applicable limits on amounts for such 

24 program or activities for a fiscal year. 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

2 For each of fiscal years 2016–2022, there are au3 thorized to be appropriated for fees under this sec4 tion $20,600,000, as adjusted by subsection (d). 

5 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

6 OF COLLECTION SHORTFALLS.— 

7 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 

8 the sum of the cumulative amount of fees col9 lected under this section for the fiscal years 

10 2016 through 2020 exceeds the cumulative 

11 amount appropriated pursuant to paragraph (3) 

12 for fiscal years 2016–2021, the excess amount 

13 shall be credited to the appropriation account of 

14 the Food and Drug Administration as provided 

15 in paragraph (1), and shall be subtracted from 

16 the amount of fees that would otherwise be au17 thorized to be collected under this section pur18 suant to appropriation Acts for fiscal year 

19 2022. 

20 ‘‘(B) RECOVERY OF COLLECTION SHORT21 FALLS.— 

22 ‘‘(i) 2018.—For fiscal year 2018, the 

23 amount of fees otherwise authorized to be 

24 collected under this section shall be in25 creased by the amount, if any, by which 


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1 the amount collected under this section 

2 and appropriated for fiscal year 2016 falls 

3 below the amount of fees authorized for 

4 fiscal year 2016 under paragraph (3). 

5 ‘‘(ii) 2019.—For fiscal year 2019, the 

6 amount of fees otherwise authorized to be 

7 collected under this section shall be in8 creased by the amount, if any, by which 

9 the amount collected under this section 

10 and appropriated for fiscal year 2017 falls 

11 below the amount of fees authorized for 

12 fiscal year 2017 under paragraph (3). 

13 ‘‘(iii) 2020.—For fiscal year 2020, 

14 the amount of fees otherwise authorized to 

15 be collected under this section shall be in16 creased by the amount, if any, by which 

17 the amount collected under this section 

18 and appropriated for fiscal year 2018 falls 

19 below the amount of fees authorized for 

20 fiscal year 2018 under paragraph (3). 

21 ‘‘(iv) 2021.—For fiscal year 2021, the 

22 amount of fees otherwise authorized to be 

23 collected under this section shall be in24 creased by the amount, if any, by which 

25 the amount collected under this section 


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1 and appropriated for fiscal year 2019 falls 

2 below the amount of fees authorized for 

3 fiscal year 2019 under paragraph (3). 

4 ‘‘(v) 2022.—For fiscal year 2022, the 

5 amount of fees otherwise authorized to be 

6 collected under this section shall be in7 creased by the amount, if any, by which 

8 the amount collected under this section 

9 and appropriated for fiscal year 2020 falls 

10 below the amount of fees authorized for 

11 fiscal year 2020 under paragraph (3). 

12 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.—The Food 

13 and Drug Administration shall not consider a registration 

14 submitted to be complete until such fee under subsection 

15 (a) is paid. Until the fee is paid, the registration is incom16 plete and the registrant is deemed to have failed to reg17 ister in accordance with section 605. 

18 ‘‘(h) FALSE STATEMENTS.—Any statement or rep19 resentation made to the Food and Drug Administration 

20 shall be subject to section 1001 of title 18, United States 

21 Code. 

22 ‘‘(i) COLLECTION OF UNPAID FEES.—In any case 

23 where the Food and Drug Administration does not receive 

24 payment of a fee assessed under subsection (a), such fee 

25 shall be treated as a claim of the United States GovernVerDate Sep 11 2014 03:48 Apr 25, 2015 Jkt 049200 PO 00000 Frm 00096 Fmt 6652 Sfmt 6201 E:\BILLS\S1014.IS S1014

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1 ment subject to subchapter II of chapter 37 of title 31, 

2 United States Code. 

3 ‘‘(j) CONSTRUCTION.—This section may not be con4 strued to require that the number of full-time equivalent 

5 positions in the Department of Health and Human Serv6 ices, for officers, employees, and advisory committees not 

7 engaged in cosmetic activities, be reduced to offset the 

8 number of officers, employees, and advisory committees so 

9 engaged. 

10 ‘‘(k) RECORDS.—Each facility shall retain all records 

11 necessary to demonstrate the facility’s gross annual sales 

12 for at least 2 fiscal years after such information is re13 ported in the facility’s registration. Such records shall be 

14 made available to the Food and Drug Administration for 

15 review and duplication upon request of the Food and Drug 

16 Administration.’’. 

17 SEC. 203. DIRECT HIRING AUTHORITY TO SUPPORT ACTIVI18 TIES RELATED TO COSMETICS. 

19 Part 10 of subchapter C of chapter VII, as added 

20 by section 202, is amended by inserting after section 744L 

21 the following: 

22 ‘‘SEC. 744M. DIRECT HIRING AUTHORITY TO SUPPORT AC23 TIVITIES RELATED TO COSMETICS. 

24 ‘‘(a) IN GENERAL.—The Food and Drug Administra25 tion shall have direct hiring authority with respect to the 


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1 appointment of employees into the competitive service or 

2 the excepted service to administer the amendments made 

3 by title I of the Personal Care Products Safety Act. 

4 ‘‘(b) SUNSET.—The authority under subsection (a) 

5 shall terminate on the date that is 3 years after the date 

6 of enactment of such title.’’. 

Æ 


smartinez on DSK4TPTVN1PROD with BILLS